PMCF Study on PEEK Suture Anchors for Shoulder Indications | NCT03826667 | Trialant
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Studies PMCF Study on PEEK Suture Anchors for Shoulder Indications NCT03826667 Show options Soft Tissue to Bone Fixation Polyetheretherketone (PEEK) Shoulder Suture Anchors Obsolete or Duplicate NCT IDs Not provided
PMCF Study on PEEK Suture Anchors for Shoulder Indications
Post-market Clinical Follow-up (PMCF) Study on PEEK Suture Anchors for Shoulder Indications
Smith & Nephew, Inc. INDUSTRY
Overall Recruitment Status or Expanded Access Status Completed
First Submission Date that Met QC Criteria Jan 30, 2019
Results First Submitted Date Oct 22, 2021
Results First Submitted that Met QC Criteria Feb 12, 2022
Results First Posted Date Apr 12, 2022 Actual
Certification/Extension (aka Delayed Results) First Submitted Date Not provided
Certification/Extension First Submitted that Passed QC Review Not provided
Certification/Extension First Posted Date Not provided
Last Update Submitted Date Feb 12, 2022
Responsible Party, by Official Title Sponsor
Smith & Nephew, Inc. INDUSTRY
Has Data Monitoring Committee (DMC) No
Pediatric Postmarket Surveillance of a Device Product Not provided
Post-market clinical follow-up on the PEEK Suture Anchors in the shoulder.
Soft Tissue to Bone Fixation Number of References to an Expanded Access Study Not provided
Target Follow-Up Duration Not provided
No data available
No data is available for this block.
Name Type Description Arm Group Labels Other Names Polyetheretherketone (PEEK) Shoulder Suture Anchors Device PEEK Suture Anchors, which include:
HEALICOIL™ PK Preloaded Suture Anchors
BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors
BIORAPTOR™ Knotless Suture Anchors
MULTIFIX™ S Ultra Knotless Fixation System
FOOTPRINT™ Ultra PK Suture Anchors
TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles
SPEEDSCREW™ Knotless Fixation System
SpeedLock Knotless Fixation Device
Measure Description Time Frame Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention Clinical success was defined as shoulder repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered "Yes" based on the following 3 main criteria:
no inflammatory or allergic response
no device-related adverse event (AE)
no device deficiencies (DDs) leading to revision surgery (re intervention) on the index shoulder
6 months
Measure Description Time Frame Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention Clinical success was defined as shoulder repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered "Yes" based on the following 3 main criteria:
no inflammatory or allergic response
no device-related adverse event (AE)
no device deficiencies (DDs) leading to revision surgery (re intervention) on the index shoulder
Inclusion Criteria:
Subjects who have undergone shoulder joint repair using the study devices.
Subjects aged 18 years and older at the time of surgery.
Exclusion Criteria:
Subjects who are < 12 months post-operative.
Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 30 days prior to surgery.
Accepts Healthy Volunteers No
Subjects who have received PEEK Suture Anchors implanted in the shoulder
Name Affiliation Role Judth Horner Smith & Nephew, Inc. Study Chair
Facility Status City State ZIP Country Contacts Grandview Medical Center Birmingham Alabama 35242 United States OrthoArizona
No data available
No data is available for this block.
It was intended to enroll participants for 8 PEEK suture anchor devices; however, no participants were enrolled for the BIORAPTOR™ Knotless Suture Anchors, resulting in 7 suture anchor groups being analyzed. A total of 464 participants were enrolled in the study and 467 joints were observed. Multiple devices were implanted in 124 participants.
ID Title Description FG000 Polyetheretherketone (PEEK) Shoulder Suture Anchors Participants who have received PEEK Suture Anchors in the shoulder which included:
HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device
Title Milestones Reasons Not Completed Overall Study Type Comment Milestone Data STARTED
Baseline Analysis Population Description
No data available
No data is available for this block.
Document Has No Statistical Analysis Plan (SAP) Not provided
Uploaded Document Information Type Includes Protocol Includes SAP Includes ICF Document Label Document Date Document Uploaded Date Document File Name Prot_SAP Yes Yes No Study Protocol and Statistical Analysis Plan Apr 1, 2019
No data available
No data is available for this block.
No data available
No data is available for this block.
No data available
No data is available for this block.
Intervention Model Description Not provided
No data available
No data is available for this block.
Visual Analog Scale (VAS) - Pain The VAS is a continuous scale comprised of a horizontal line 100 millimeters (mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. The VAS pain score is presented on a scale ranging from 0 to 10. A score of 0 represents no pain (0 mm) and a score of 10 indicates extreme/unbearable pain (100 mm). The VAS rating was recorded retrospectively, per standard of care at 6 and 12 months post-surgery.
6 and 12 months
Count of Participants With Range of Motion (ROM) Full Functional Arc Range of motion defined as the participant having a full functional arc "Yes" or "No" at 6 month and 12 month post-operative visits.
6 and 12 months
Range of Motion (ROM) Forward flexion angle, internal rotation angle, and external rotation angle captured in degrees based on physician's Standard of Care.
6 and 12 months
University of Colorado- Denver Denver Colorado 80222 United States
Holy Cross Hospital/Orthopedic Institute Fort Lauderdale Florida 33334 United States
OrthoAtlanta Lawrenceville Georgia 30046 United States
Community Hospital Oklahoma City Oklahoma 73114 United States
University Orthopedics Center Altoona Pennsylvania 16602 United States
Houston Methodist at Baytown Baytown Texas 77521 United States
Texas Orthopedic Hospital - Houston Houston Texas 77030 United States
Aspen Orthopedics at New Berlin New Berlin Wisconsin 53151 United States
Aspen Orthopedics at West Allis West Allis Wisconsin 80222 United States
FG000 464 subjects 467 units HEALICOIL™ PK Preloaded Suture Anchors Type of suture anchor received at start
FG000 193 subjects 193 units
BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors Type of suture anchor received at start
MULTIFIX™ S Ultra Knotless Fixation System Type of suture anchor received at start
FOOTPRINT™ Ultra PK Suture Anchors Type of suture anchor received at start
FG000 136 subjects 138 units
TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and With Needles Type of suture anchor received at start
SPEEDSCREW™ Knotless Fixation System Type of suture anchor received at start
SpeedLock Knotless Fixation Device Type of suture anchor received at start
COMPLETED FG000 443 subjects 446 units
Type Comment Reasons Protocol deviation
Participants enrolled in the study who had previously undergone shoulder repair using PEEK suture anchors (i.e., retrospective data). The type(s) of PEEK anchor used during surgery was surgeon decision on a case by case basis. Multiple anchor types could be used in one surgery if required. 124 participants had multiple devices implanted. Participants with bilateral surgeries had both surgeries recorded independently. Device data analyzed individually dependent on unique suture anchor implanted.
ID Title Description BG000 Polyetheretherketone (PEEK) Shoulder Suture Anchors Participants who have received PEEK Suture Anchors in the shoulder which included:
HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device
Units Counts Participants joints
Title Description Population Description Parameter Type Dispersion Type Unit of Measure Calculate Percentage Denominator Units Selected Denominators Classes Age, Continuous Mean Standard Deviation years joints Units Counts Participants joints
Title Denominators Categories
Sex: Female, Male Count of Units joints joints Units Counts Participants joints
Title Denominators Categories
Ethnicity (NIH/OMB) Count of Units joints joints Units Counts Participants joints
Title Denominators Categories
Race/Ethnicity, Customized Count of Units joints joints Units Counts Participants joints
Title Denominators Categories American Indian or Alaska Native
Region of Enrollment Number joints joints Units Counts Participants joints
Title Denominators Categories United States
Location of Device Implantation Count of Units joints joints Units Counts Participants joints
Title Denominators Categories
Duration of Surgery Data was not available for all participants due to the retrospective nature of the study.
Mean Standard Deviation minutes Participants Units Counts Participants joints
Title Denominators Categories
Duration of time from injury to surgery Data not available for all participants due to the retrospective nature of the study.
Mean Standard Deviation days Participants Units Counts Participants joints
Title Denominators Categories
Any Medical History Count of Units joints joints Units Counts Participants joints
Title Denominators Categories
Number of Participant Joints Treated by Indication Count of Units joints joints Units Counts Participants joints
Title Denominators Categories
Disposition of Suture Anchors Count of participants by unique PEEK Suture Anchors implanted.
Information provided based on the unique device implanted. Out of 464 overall participants, 124 were implanted with multiple Suture Anchors (devices).
Count of Participants Participants Participants Units Counts Participants joints
Type Title Description Population Description Reporting Status Anticipated Posting Date Parameter Type Dispersion Type Unit of Measure Calculate Percentage Time Frame Units Analyzed Denominator Units Selected Arm/Group Information Denominators Classes Analyses Primary Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 6 Months After Intervention Clinical success was defined as shoulder repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered "Yes" based on the following 3 main criteria:
no inflammatory or allergic response
no device-related adverse event (AE)
no device deficiencies (DDs) leading to revision surgery (re intervention) on the index shoulder
Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed.
Posted Count of Participants Participants 6 months ID Title Description OG000 Polyetheretherketone (PEEK) Shoulder Suture Anchors Participants who have received PEEK Suture Anchors in the shoulder which included:
HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device
Title Denominators Categories HEALICOIL™ PK Preloaded Suture Anchors
Secondary Number of Participants With Clinical Success of the Study Devices in the Shoulder Over a Time Period of 12 Months After Intervention Clinical success was defined as shoulder repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered "Yes" based on the following 3 main criteria:
no inflammatory or allergic response
no device-related adverse event (AE)
no device deficiencies (DDs) leading to revision surgery (re intervention) on the index shoulder
Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed.
Posted Count of Participants Participants 12 months ID Title Description OG000 Polyetheretherketone (PEEK) Shoulder Suture Anchors Participants who have received PEEK Suture Anchors in the shoulder which included:
HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device
Secondary Visual Analog Scale (VAS) - Pain The VAS is a continuous scale comprised of a horizontal line 100 millimeters (mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. The VAS pain score is presented on a scale ranging from 0 to 10. A score of 0 represents no pain (0 mm) and a score of 10 indicates extreme/unbearable pain (100 mm). The VAS rating was recorded retrospectively, per standard of care at 6 and 12 months post-surgery.
Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed.
Posted Mean Standard Deviation score on a scale 6 and 12 months ID Title Description OG000 Polyetheretherketone (PEEK) Shoulder Suture Anchors Participants who have received PEEK Suture Anchors in the shoulder which included:
HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device
Secondary Count of Participants With Range of Motion (ROM) Full Functional Arc Range of motion defined as the participant having a full functional arc "Yes" or "No" at 6 month and 12 month post-operative visits.
Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed.
Posted Count of Participants Participants 6 and 12 months ID Title Description OG000 Polyetheretherketone (PEEK) Shoulder Suture Anchors Participants who have received PEEK Suture Anchors in the shoulder which included:
HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device
Secondary Range of Motion (ROM) Forward flexion angle, internal rotation angle, and external rotation angle captured in degrees based on physician's Standard of Care.
Number of participants analyzed at the specified time frame for each row indicates participant provided retrospective data for the PEEK Suture Anchor identified. Some participants were implanted with multiple Suture Anchors (devices).Data was analyzed independently based on specific device implanted (i.e., participants with multiple devices were analyzed individually by unique suture anchor). Overall number of participants analyzed indicates combined total of distinct participants assessed.
Posted Mean Standard Deviation degrees 6 and 12 months ID Title Description OG000 Polyetheretherketone (PEEK) Shoulder Suture Anchors Participants who have received PEEK Suture Anchors in the shoulder which included:
HEALICOIL™ PK Preloaded Suture Anchors, BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors, MULTIFIX™ S Ultra Knotless Fixation System, FOOTPRINT™ Ultra PK Suture Anchors, TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles, SPEEDSCREW™ Knotless Fixation System, SpeedLock Knotless Fixation Device
Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 464 participants were enrolled in the study. However, there were 124 participants with multiple devices implanted. Participant Suture Anchor data analyzed independently based on device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
All-Cause Mortality Comment Not provided
ID Title Description Deaths (Affected) Deaths (At Risk) Serious Events (Affected) Serious Events (At Risk) Other Events (Affected) Other Events (At Risk) EG000 HEALICOIL™ PK Preloaded Suture Anchors Participants who have received PEEK Suture Anchor:
HEALICOIL™ PK Preloaded Suture Anchors
0 193 15 193 40 193 EG001 BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors Participants who have received PEEK Suture Anchor:
BIORAPTOR™ 2.3 PK Suture Anchors/BIORAPTOR™ Curved 2.3 PK Suture Anchors
0 41 7 41 27 41 EG002 MULTIFIX™ S Ultra Knotless Fixation System Participants who have received PEEK Suture Anchor:
MULTIFIX™ S Ultra Knotless Fixation System
0 78 13 78 38 78 EG003 FOOTPRINT™ Ultra PK Suture Anchors Participants who have received PEEK Suture Anchor:
FOOTPRINT™ Ultra PK Suture Anchors
0 136 10 136 24 136 EG004 TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and With Needles Participants who have received PEEK Suture Anchor:
TWINFIX™ Ultra PK Suture Anchors/TWINFIX™ Ultra Preloaded and with Needles
0 57 1 57 5 57 EG005 SPEEDSCREW™ Knotless Fixation System Participants who have received PEEK Suture Anchor:
SPEEDSCREW™ Knotless Fixation System
0 59 4 59 4 59 EG006 SpeedLock Knotless Fixation Device Participants who have received PEEK Suture Anchor:
SpeedLock Knotless Fixation Device
0 18 0 18 0 18
Term Organ System Source Vocabulary Assessment Type Notes Statistical Information ADHESIVE CAPSULITIS IN RIGHT SHOULDER Musculoskeletal and connective tissue disorders Non-systematic Assessment Unlikely related to device
EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 0 events 0 affected 136 at risk PULMONARY EMBOLUS Blood and lymphatic system disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 RE-TEAR OF ROTATOR CUFF Injury, poisoning and procedural complications Non-systematic Assessment EG000 2 events 2 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 RIGHT CARPAL TUNNEL WITH RELEASE Nervous system disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 LEFT SHOULDER RECURRENT ROTATOR CUFF TEAR Injury, poisoning and procedural complications Non-systematic Assessment Possibly related to device
EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 R RECURRENT RTC TEAR AND IMPINGEMENT SYNDROME Injury, poisoning and procedural complications Non-systematic Assessment Possibly related to device
EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 RECURRENT TEAR OF ROTATOR CUFF WITH NEW TEAR OF THE SUPRASPINATUS AND RECURRENT JOINT IMPINGEMENT Injury, poisoning and procedural complications Non-systematic Assessment Possibly related to device
EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 LEFT SHOULDER ADHESIVE CAPSULITIS Musculoskeletal and connective tissue disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 LEFT SHOULDER PAIN WITH RECURRENT RTC TEAR General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 DECREASED ROM RIGHT SHOULDER Musculoskeletal and connective tissue disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 RIGHT SHOULDER INCREASE IN PAIN WITH POPPING AND GRINDING, RECURRENT RTC TEAR General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 CONTINUING WEAKNESS RIGHT SHOULDER AND DECREASED ROM Musculoskeletal and connective tissue disorders Non-systematic Assessment Possibly related to device
EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 LEFT SHOULDER PAIN AND DECREASED ROM Musculoskeletal and connective tissue disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 RECURRENT RTC TEAR Musculoskeletal and connective tissue disorders Non-systematic Assessment EG000 2 events 2 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 2 events 2 affected 78 at risk EG003 R SHOULDER INCREASED PAIN, WEAKNESS, LTD. ROM, R RECURRENT RTC TEAR General disorders Non-systematic Assessment Possibly related to device
EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 RIGHT SHOULDER ADHESIVE CAPSULITIS Musculoskeletal and connective tissue disorders Non-systematic Assessment Possibly related to device
EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 R SHOULDER SUBACHROMIAL BURSITIS WITH SUPRASPINATOUS TENDINOSIS CAUSING DECREASED MOBILITY Musculoskeletal and connective tissue disorders Non-systematic Assessment Possibly related to device
EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 LEFT SHOULDER PAIN AND WEAKNESS RELATED TO RECURRENT RTC TEAR General disorders Non-systematic Assessment Possibly related to device
EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 RIGHT SHOULDER PAIN, TIGHTNESS AND SPASM WITH PERSISTENT WEAKNESS AND RECURRENT RTC TEAR Musculoskeletal and connective tissue disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 FELT POP R SHOULDER, DECREASED ROM AND PAIN SINCE, RECURRENT RTC TEAR General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 LEFT SHOULDER SWELLING AND PAIN AFTER PT STRETCH AND RECURRENT LEFT RTC TEAR General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 R SHOULDER PAIN CREPITUS AND STIFFNESS WITH RECURRENT RTC TEAR, General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 RIGHT SHOULDER PAIN AND WEAKNESS, RECURRENT R RTC TEAR, General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 INCREASED PAIN, DECREASED ROM AND WEAKNESS, RECURRENT L RTC TEAR, INSOMNIA R/T PAIN General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 WORSENING LEFT SHOULDER PAIN RADIATING DOWN LEFT ARM, RECURRENT LABRAL TEAR General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 LEFT RTC TEAR, RTC CAPSULE SPRAIN Injury, poisoning and procedural complications Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 LEFT SHOULDER PAIN WITH DECREASED ROM, STIFF AND SORE, ADHESIVE CAPSULITIS AND RTC TENDONITIS General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 RIGHT SHOULDER PAIN, LTD ROM, RTC TEAR General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 OCCASIONAL LEFT SHOULDER PAIN, STIFFNESS, ADHESIVE CAPSULITIS Surgical and medical procedures Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 R SHOULDER TENDONITIS, PARTIAL RTC TEAR Injury, poisoning and procedural complications Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 R SHOULDER ANTERIOR WOUND INFECTION Infections and infestations Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 R SHOULDER PAIN, RECURRENT RTC TEAR General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 R RTC TEAR, TENDONITIS AND WEAKNESS Injury, poisoning and procedural complications Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 CLAVICLE FRACTURE AFTER FALL AT WORK Injury, poisoning and procedural complications Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 SPLENIC NECROSIS Blood and lymphatic system disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 PNEMOTHORAX- RIGHT Respiratory, thoracic and mediastinal disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003
Term Organ System Source Vocabulary Assessment Type Notes Statistical Information COMPLEX REGIONAL PAIN SYNDROME TYPE II General disorders Non-systematic Assessment Unlikely related to device
EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 0 events 0 affected 136 at risk PAIN ON THE RIGHT SIDE OF HER SHOULDER DOWN HER NECK AND THE MEDIAL BORDER OF HER RIGHT SCAPULA. General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 RIGHT SIDE ARM PAIN General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 SHOULDER PAIN POST FALL General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 LEFT HAND NUMBNESS General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 LEFT SHOULDER TENDINITIS/BURSITIS Musculoskeletal and connective tissue disorders Non-systematic Assessment Unlikely related to device
EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 RIGHT SHOULDER DISCOMFORT SECONDARY TO FALL Injury, poisoning and procedural complications Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 ADHESIVE CAPSULITIS Musculoskeletal and connective tissue disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 LEFT SHOULDER ANTERIOR PORTAL REDDENED AND SWOLLEN WITH RESOLVING BICEP ECCHYMOSIS Skin and subcutaneous tissue disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 RIGHT SHOULDER PAIN General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 CONTINUED LEFT SHOULDER WEAKNESS General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 ACTIVE RANGE OF MOTION LIMITED BY PAIN General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 BICEPS ATROPHY Musculoskeletal and connective tissue disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 SHOOTING PAIN DOWN LEFT ARM General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 RIGHT HAND CONTUSION General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 ADHESIVE CAPSULITIS RIGHT SHOULDER Musculoskeletal and connective tissue disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 INCREASE IN RIGHT SHOULDER PAIN General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 NEW ONSET ATRIAL FIBRILLATION Cardiac disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 RIGHT ARM LIMITED ROM SECONDARY RIGHT SHOULDER PAIN FROM LIFTING INJURY General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 RIGHT BICEPS TENDONITIS Musculoskeletal and connective tissue disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 RIGHT SHOULDER ADHESIVE CAPSULITIS POST RCR Musculoskeletal and connective tissue disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 PAINFUL HERNIATED CERVICAL DISC WITH MYELOPATHY Musculoskeletal and connective tissue disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 BILATERAL SHOULDER PAIN General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 LEFT SHOULDER INCREASING PAIN General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 LEFT SHOULDER CLICKING, NUMBNESS LEFT ARM, LEFT 4TH AND 5TH FINGERS General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 NIGHTMARES FROM PERCOCET Psychiatric disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 INSOMNIA R/T LEFT SHOULDER PAIN General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 LEFT SHOULDER PAIN WITH EXERCISING General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 LEFT SHOULDER STIFFNESS General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 LEFT SHOULDER SORENESS General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 EXACERBATION HYPERTENSION Vascular disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 BICEPS TENDONITIS RIGHT SHOULDER Musculoskeletal and connective tissue disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 NUMBNESS RIGHT THUMB General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 HERNIATED DISC WITH MYELOPATHY, CONTINUED RIGHT ARM WEAKNESS, RIGHT SCAPULA AREA AND SHOULDER PAIN General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 WORSENING RIGHT SHOULDER PAIN AND SWELLING General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 FALL CAUSING RIGHT SHOULDER FORCED ABDUCTION Injury, poisoning and procedural complications Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 RIGHT SHOULDER SORENESS AT TIMES General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 ROTATOR CUFF SPRAIN/STRAIN LEFT SHOULDER Injury, poisoning and procedural complications Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 INSOMNIA SECONDARY TO RIGHT SHOULDER PAIN General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 LEFT HAND THIRD FINGER PARONYCHIA VERY PAINFUL AND TENDER Infections and infestations Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 POSTERIOR/LATERAL NUMBNESS RIGHT ARM General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 RIGHT SHOULDER SWELLING General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 PAINFUL ROM General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 RECURRENT 6MM RIGHT RTC TEAR SECONDARY TO DIABETES AND SMOKING CAUSING POOR TISSUE QUALITY Endocrine disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 INCREASING RIGHT SHOULDER PAIN General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 ROTATOR CUFF SPRAIN/STRAIN RIGHT SHOULDER Injury, poisoning and procedural complications Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 CONTINUING SHOULDER PAIN General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 2 events 2 affected 41 at risk EG002 3 events 3 affected 78 at risk EG003 PAIN DOWN ARM TO LEFT HAND 4TH AND 5TH FINGERS General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 LEFT SHOULDER BURSITIS General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 LEFT SHOULDER PAIN WITH DECREASED ROM General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 LEFT SHOULDER PAIN AFTER PT STRENGTHENING EXERCISES General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 LEFT LATERAL EPICONDYLITIS Musculoskeletal and connective tissue disorders Non-systematic Assessment EG000 2 events 2 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 2 events 2 affected 78 at risk EG003 LEFT TRICEPS TENDONITIS Musculoskeletal and connective tissue disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 TINGLING FROM LEFT ELBOW TO WRIST General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 LEFT ELBOW WARM TO TOUCH WITH DECREASED MOBILITY AND PAIN RADIATING TO WRIST General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 SHOULDER PAIN General disorders Non-systematic Assessment EG000 2 events 2 affected 193 at risk EG001 4 events 4 affected 41 at risk EG002 2 events 2 affected 78 at risk EG003 INCREASED RIGHT SHOULDER PAIN R/T FALL Injury, poisoning and procedural complications Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 RIGHT SHOULDER INCREASED PAIN AND STIFFNESS R/T CATCHING FALLING CLIENT Injury, poisoning and procedural complications Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 RIGHT ANKLE SPRAIN WITH SWELLING AND PAIN R/T FALL Injury, poisoning and procedural complications Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 RIGHT SHOULDER LIMITED ROM AND WEAKNESS General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 INCREASED PAIN RIGHT ANKLE General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 WORSENING PAIN RIGHT SHOULDER General disorders Non-systematic Assessment Possibly related to device
EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 RIGHT SHOULDER IMPINGEMENT SYNDROME, WITH LIMITED ADLS AND NIGHT PAIN Injury, poisoning and procedural complications Non-systematic Assessment Possibly related to device
EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 NOCTURNAL AWAKENING DUE TO RIGHT SHOULDER TENDINOSIS Musculoskeletal and connective tissue disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 RIGHT SHOULDER SWELLING, REDNESS, WARMTH AND PAIN, CELLULITIS Infections and infestations Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 LEFT SHOULDER PAIN, STIFFNESS, NUMBNESS AND DECREASED SENSATION RELATED TO RECURRENT RTC TEAR General disorders Non-systematic Assessment Possibly related to device
EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 RIGHT SHOULDER ACHING PAIN WITH CERTAIN MOVEMENTS General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 LEFT SHOULDER MILD PAIN AND WEAKNESS General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 DECREASED LEFT SHOULDER STRENGTH General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 LEFT SHOULDER DECREASED ROM AND STRENGTH RELATED RTC RUPTURE General disorders Non-systematic Assessment Possibly related to device
EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 LEFT SHOULDER PAIN WITH DECREASED ROM General disorders Non-systematic Assessment Possibly related to device
EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 LEFT SHOULDER CONSTANT PAIN AND WEAKNESS RELATED TO RECURRENT RTC TEAR General disorders Non-systematic Assessment Possibly related to device
EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 LEFT ARM PAIN BICEP REGION AND LEFT SHOULDER SWELLING General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 SMALL PARTIAL THICKNESS LEFT SUPRASPINATUS TEAR Musculoskeletal and connective tissue disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 OCCASIONAL SHOULDER PAIN General disorders Non-systematic Assessment EG000 2 events 2 affected 193 at risk EG001 3 events 3 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 NAUSEA AND CONSTIPATION R/T POST-OP OXYCONTIN Gastrointestinal disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 DISCOMFORT RIGHT BICEP INTO NECK AND DISUSE ATROPHY Musculoskeletal and connective tissue disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 RIGHT SHOULDER PAIN AND WEAKNESS General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 LEFT SHOULDER DULL PAIN AFTER STRENUOUS ACTIVITY General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 INTERMITTENT LEFT SHOULDER PAIN SINCE EXERCISING General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 INTERMITTENT EPISODES OF PERSPIRING AND FEELING OF EXHAUSTION General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 LEFT SHOULDER DECREASED ROM General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 DIVERTICULITIS Gastrointestinal disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 LEFT SHOULDER WEAKNESS AND PAIN General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 INTERMITTENT LEFT BICEP PAIN AND CRAMPING General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 INCREASED LUE PAIN WITH NUMBNESS AND TINGLING TO LEFT RADIAL DIGITS AND INSOMNIA RELATED TO PAIN General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 INCREASING LEFT SHOULDER PAIN General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 LEFT SHOULDER BURSITIS WITH DECREASED ROM AND WEAKNESS Musculoskeletal and connective tissue disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 THUMB PAIN General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 LEFT SHOULDER PAIN AND RESIDUAL WEAKNESS General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 LEFT SHOULDER PAIN, LTD. ROM, WEAKNESS, DISUSE ATROPHY General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 LEFT RTC SMALL PARTIAL THICKNESS TEAR Injury, poisoning and procedural complications Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 LEFT SHOULDER STIFFNESS, CONSTANT SORENESS, DECREASED ROM, ACHING AND WEAKNESS General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 RIGHT ANTERIOR SHIN NEURALGIA/SPRAIN General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 MIGRAINE HEADACHES General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 OCCASIONAL DEEP LEFT SHOULDER PAIN General disorders Non-systematic Assessment Possibly related to device
EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 LEFT ARM WEAKNESS General disorders Non-systematic Assessment Possibly related to device
EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 ABDOMINAL PAIN AND CONSTIPATION Gastrointestinal disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 L SHOULDER PAIN W/LTD. ROM AND STRENGTH General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 LEFT SHOULDER EDEMA Injury, poisoning and procedural complications Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 INCREASED LEFT SHOULDER PAIN, HYPERSENSITIVITY AND PARASTHESIA, QUESTION POSSIBLE RSD General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 CELLULITIS AND PURULENT DRAINAGE LEFT SHOULDER WOUND Infections and infestations Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 INTERMITTENT LEFT SHOULDER PAIN General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 RIGHT SHOULDER PAIN WITH DECREASED ROM General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 RIGHT SHOULDER PAIN WITH TIGHTNESS, WEAKNESS, AND DECREASED ROM General disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 1 events 1 affected 78 at risk EG003 RECURRENT RTC TEAR Injury, poisoning and procedural complications Non-systematic Assessment EG000 2 events 2 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 2 events 2 affected 78 at risk EG003 INTERMITTENT RIGHT SHOULDER PAIN General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 LEFT SHOULDER ANTERIOR INCISIONS WITH MILD CELLULITIS Infections and infestations Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 WORSENING LEFT SHOULDER PAIN AND SWELLING DUE TO FALLING IN SHOWER, CATCHING HERSELF WITH LEFT ARM Injury, poisoning and procedural complications Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 LEFT SHOULDER STIFFNESS AND LTD. ROM General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 LEFT SHOULDER MILD TENDINOSIS, POSSIBLE SLAP TEAR Musculoskeletal and connective tissue disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 RIGHT ROTATOR CUFF TENDONITIS, ACJ IMPINGEMENT Injury, poisoning and procedural complications Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 RIGHT SHOULDER SWELLING AND PAIN General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 LEFT SHOULDER STIFFNESS "SLEPT ON IT WRONG" General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 OCCASIONAL LEFT SHOULDER DECREASED ROM, PAIN, AND WEAKNESS General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 SLIPPED OFF CURB AND FELL ONTO LEFT ARM Injury, poisoning and procedural complications Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 PAIN FROM LEFT SHOULDER STRAIN Injury, poisoning and procedural complications Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 RETURNING LEFT SHOULDER PAIN General disorders Non-systematic Assessment Unlikely related to device
EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 R SHOULDER PAIN, DECREASED ROM AND BICEPS AREA PAIN General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 RIGHT SHOULDER SURGICAL SCAR SENSITIVITY Injury, poisoning and procedural complications Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 PALPABLE TIGHTNESS RIGHT TRAPEZIUS AREA Musculoskeletal and connective tissue disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 LEFT SHOULDER INTERMITTENT PAIN AND DECREASED ROM General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 CONTINUING RIGHT SHOULDER PAIN AND DECREASED ROM General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 REACHING IN PT AND FELT A "POP" WITH INCREASED PAIN RIGHT SHOULDER General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 RAISED RASH RIGHT FOREARM AND RIGHT ARMPIT Skin and subcutaneous tissue disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 NAUSEA FROM PAIN MEDICATION Gastrointestinal disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 REDNESS AND SWELLING AROUND INCISION FRONT OF RIGHT SHOULDER Injury, poisoning and procedural complications Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 RIGHT BICIPITAL GROOVE TENDERNESS AFTER OVERSTRETCHING IN PT Injury, poisoning and procedural complications Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 WORSENING PAIN RIGHT SHOULDER General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 GLENOHUMERAL INTERNAL ROTATION DEFICIT RIGHT SHOULDER Musculoskeletal and connective tissue disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 LEFT SHOULDER CONTINUING PAIN General disorders Non-systematic Assessment Possibly related to device
EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 LEFT SHOULDER STIFFNESS Musculoskeletal and connective tissue disorders Non-systematic Assessment Possibly related to device
EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 WORSENING LEFT SHOULDER PAIN AND DECREASED ROM Gastrointestinal disorders Non-systematic Assessment Possibly related to device
EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 LEFT KNEE ARTHROFIBROSIS Musculoskeletal and connective tissue disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 RIGHT SHOULDER PAIN AT NIGHT General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 CONTINUED POST-OP REVISION LEFT SHOULDER PAIN Injury, poisoning and procedural complications Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 POSSIBLE LEFT CUBITAL TUNNEL SYNDROME Injury, poisoning and procedural complications Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 LEFT SHOULDER POST. INCISION OPEN W/BLOOD DRAINAGE- SUTURE FELL OUT General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 LEFT SHOULDER WORSENING PAIN, LTD ROM General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 ULNAR NERVE SYMPTOMS AND MEDIAL SCAPULAR PAIN, NECK PAIN Nervous system disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 HERNIATED DISC WITH MYELOPATHY Nervous system disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 RECURRING RIGHT ELBOW PAIN, ACUTE RIGHT EPICONDYLITIS General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 L SHOULDER PAIN, DECREASED ROM W/DIFFICULTY SLEEPING @ NIGHT, POSSIBLE ADHESIVE CAPSULITIS General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 LEFT ELBOW PAIN General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 LEFT ELBOW STIFFNESS Musculoskeletal and connective tissue disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 RIGHT FOREARM PAIN AND MUSCLE SPASMS General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 RIGHT SHOULDER INSTABILITY AND PAIN R/T STRAIN/SPRAIN General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 LEFT SHOULDER PAIN POST MUA, LOA Injury, poisoning and procedural complications Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 RECURRENT RIGHT SHOULDER PAIN, POST-OP REVISION General disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 RIGHT SHOULDER MUSCLE SPASMS Musculoskeletal and connective tissue disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 1 events 1 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 RIGHT ROTATOR CUFF RE-TEAR Injury, poisoning and procedural complications Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 ROTATOR CUFF RETEAR Injury, poisoning and procedural complications Non-systematic Assessment Unlikely related to device
EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 SEVERE CENTRAL SPINAL STENOSIS Nervous system disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 HERPES ZOSTER Skin and subcutaneous tissue disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 HYPERLIPIDEMIA Blood and lymphatic system disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 GENERALIZED ANXIETY DISORDER Psychiatric disorders Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 RIGHT ELBOW INJURY, POSSIBLE FRACTURE, OCCURRED DUE TO FALL Injury, poisoning and procedural complications Non-systematic Assessment EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 MASS OF SOFT TISSUE OF RIGHT UPPER EXTREMITY Musculoskeletal and connective tissue disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 ADD Psychiatric disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 HYPERTENSION Blood and lymphatic system disorders Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 INFECTION/SMALL HEMATOMA Infections and infestations Non-systematic Assessment EG000 1 events 1 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003 ROTATOR CUFF FAILURE / RECURRENT TEAR Injury, poisoning and procedural complications Non-systematic Assessment Possibly related to device
EG000 0 events 0 affected 193 at risk EG001 0 events 0 affected 41 at risk EG002 0 events 0 affected 78 at risk EG003
Are all PI(s) employees of the sponsor? No
Results Disclosure Restriction on PI(s)? Yes
Title Organization Phone Extension Email Judith Horner Smith+Nephew, Inc. +44 1482 673251 Judith.horner@smith-nephew.com
Hispanic or Latino Not Hispanic or Latino Unknown or Not Reported
Black or African American
Native Hawaiian or Other Pacific Islander
Title Measurements Left Shoulder Right Shoulder Bilaterally
Title Measurements Bankart lesion repair SLAP lesion repair Capsular shift Rotator cuff repair Biceps tenodesis Other
HEALICOIL™ PK Preloaded Suture Anchors BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor MULTIFIX™ S Ultra Knotless Fixation System FOOTPRINT™ Ultra PK Suture Anchor TWINFIX™ Ultra PK Suture Anchor SPEEDSCREW™ Knotless Fixation System SpeedLock Knotless Fixation Device
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BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor
MULTIFIX™ S Ultra Knotless Fixation System
FOOTPRINT™ Ultra PK Suture Anchor
TWINFIX™ Ultra PK Suture Anchor
SPEEDSCREW™ Knotless Fixation System
SpeedLock Knotless Fixation Device
Title Denominators Categories HEALICOIL™ PK Preloaded Suture Anchors BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor MULTIFIX™ S Ultra Knotless Fixation System FOOTPRINT™ Ultra PK Suture Anchor TWINFIX™ Ultra PK Suture Anchor SPEEDSCREW™ Knotless Fixation System SpeedLock Knotless Fixation Device
Title Denominators Categories HEALICOIL™ PK Preloaded Suture Anchors: 6 months HEALICOIL™ PK Preloaded Suture Anchors: 12 months BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 6 months BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 12 months MULTIFIX™ S Ultra Knotless Fixation System: 6 months MULTIFIX™ S Ultra Knotless Fixation System: 12 months FOOTPRINT™ Ultra PK Suture Anchor: 6 months FOOTPRINT™ Ultra PK Suture Anchor: 12 months TWINFIX™ Ultra PK Suture Anchor: 6 months TWINFIX™ Ultra PK Suture Anchor: 12 months SPEEDSCREW™ Knotless Fixation System: 6 months SPEEDSCREW™ Knotless Fixation System: 12 months SpeedLock Knotless Fixation Device: 6 months SpeedLock Knotless Fixation Device: 12 months
Title Denominators Categories HEALICOIL™ PK Preloaded Suture Anchors: 6 months Title Measurements Has full functional arc: Yes Has full functional arc: No Has full functional arc: Unknown
HEALICOIL™ PK Preloaded Suture Anchors: 12 months Title Measurements Has full functional arc: Yes Has full functional arc: No Has full functional arc: Unknown
BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 6 months Title Measurements Has full functional arc: Yes Has full functional arc: No
BIORAPTOR™ 2.3 PK Suture Anchor / BIORAPTOR™ Curved 2.3 PK Suture Anchor: 12 months Title Measurements Has full functional arc: Yes Has full functional arc: No
MULTIFIX™ S Ultra Knotless Fixation System: 6 months Title Measurements Has full functional arc: Yes Has full functional arc: No Has full functional arc: Unknown
MULTIFIX™ S Ultra Knotless Fixation System: 12 months Title Measurements Has full functional arc: Yes Has full functional arc: No Has full functional arc: Unknown
FOOTPRINT™ Ultra PK Suture Anchor: 6 months Title Measurements Has full functional arc: Yes Has full functional arc: No Has full functional arc: Unknown
FOOTPRINT™ Ultra PK Suture Anchor: 12 months Title Measurements Has full functional arc: Yes Has full functional arc: No Has full functional arc: Unknown
TWINFIX™ Ultra PK Suture Anchor: 6 months Title Measurements Has full functional arc: Yes Has full functional arc: No Has full functional arc: Unknown
TWINFIX™ Ultra PK Suture Anchor: 12 months Title Measurements Has full functional arc: Yes Has full functional arc: No Has full functional arc: Unknown
SPEEDSCREW™ Knotless Fixation System: 6 months Title Measurements Has full functional arc: Yes Has full functional arc: No Has full functional arc: Unknown
SPEEDSCREW™ Knotless Fixation System: 12 months Title Measurements Has full functional arc: Yes Has full functional arc: No Has full functional arc: Unknown
SpeedLock Knotless Fixation Device: 6 months Title Measurements Has full functional arc: Yes Has full functional arc: No Has full functional arc: Unknown
SpeedLock Knotless Fixation Device: 12 months Title Measurements Has full functional arc: Yes Has full functional arc: No Has full functional arc: Unknown
OG000 70 Title Denominators Categories HEALICOIL™ PK Preloaded Suture Anchors: Forward Flexion Angle (6 months) HEALICOIL™ PK Preloaded Suture Anchors: Internal Rotation Angle (6 months) HEALICOIL™ PK Preloaded Suture Anchors: External Rotation (6 months) HEALICOIL™ PK Preloaded Suture Anchors Forward Flexion Angle (12 months) HEALICOIL™ PK Preloaded Suture Anchors Internal Rotation Angle (12 months) HEALICOIL™ PK Preloaded Suture Anchors External Rotation (12 months) BIORAPTOR™ 2.3 PK /BIORAPTOR™ Curved 2.3 PK Suture Anchor: Forward Flexion Angle (6 months) BIORAPTOR™ 2.3 PK /BIORAPTOR™ Curved 2.3 PK Suture Anchor: Internal Rotation Angle (6 months) BIORAPTOR™ 2.3 PK /BIORAPTOR™ Curved 2.3 PK Suture Anchor: External Rotation (6 months) BIORAPTOR™ 2.3 PK /BIORAPTOR™ Curved 2.3 PK Suture Anchor: Forward Flexion Angle (12 months) BIORAPTOR™ 2.3 PK /BIORAPTOR™ Curved 2.3 PK Suture Anchor: Internal Rotation Angle (12 months) BIORAPTOR™ 2.3 PK /BIORAPTOR™ Curved 2.3 PK Suture Anchor: External Rotation (12 months) MULTIFIX™ S Ultra Knotless Fixation System: Forward Flexion Angle (6 months) MULTIFIX™ S Ultra Knotless Fixation System: Internal Rotation Angle (6 months) Title Measurements OG000 90 ± NA Standard deviation not calculated whenever there was only 1 participant's data available
MULTIFIX™ S Ultra Knotless Fixation System: External Rotation (6 months) MULTIFIX™ S Ultra Knotless Fixation System: Forward Flexion Angle (12 months) MULTIFIX™ S Ultra Knotless Fixation System: Internal Rotation Angle (12 months) MULTIFIX™ S Ultra Knotless Fixation System: External Rotation (12 months) FOOTPRINT™ Ultra PK Suture Anchor: Forward Flexion Angle (6 months) FOOTPRINT™ Ultra PK Suture Anchor: Internal Rotation Angle (6 months) FOOTPRINT™ Ultra PK Suture Anchor: External Rotation (6 months) FOOTPRINT™ Ultra PK Suture Anchor: Forward Flexion Angle (12 months) FOOTPRINT™ Ultra PK Suture Anchor: Internal Rotation Angle (12 months) FOOTPRINT™ Ultra PK Suture Anchor: External Rotation (12 months) TWINFIX™ Ultra PK Suture Anchor: Forward Flexion Angle (6 months) TWINFIX™ Ultra PK Suture Anchor: Internal Rotation Angle (6 months) TWINFIX™ Ultra PK Suture Anchor: External Rotation (6 months) TWINFIX™ Ultra PK Suture Anchor: Forward Flexion Angle (12 months) TWINFIX™ Ultra PK Suture Anchor: Internal Rotation Angle (12 months) TWINFIX™ Ultra PK Suture Anchor: External Rotation (12 months) SPEEDSCREW™ Knotless Fixation System: Forward Flexion Angle (6 months) SPEEDSCREW™ Knotless Fixation System: Internal Rotation Angle (6 months) SPEEDSCREW™ Knotless Fixation System: External Rotation (6 months) SPEEDSCREW™ Knotless Fixation System: Forward Flexion Angle (12 months) Title Measurements OG000 130 ± NA Standard deviation not calculated whenever there was only 1 participant's data available
SPEEDSCREW™ Knotless Fixation System: Internal Rotation Angle (12 months) SPEEDSCREW™ Knotless Fixation System: External Rotation (12 months) Title Measurements OG000 50 ± NA Standard deviation not calculated whenever there was only 1 participant's data available
SpeedLock Knotless Fixation Device: Forward Flexion Angle (6 months) SpeedLock Knotless Fixation Device: Internal Rotation Angle (6 months) SpeedLock Knotless Fixation Device: External Rotation (6 months) SpeedLock Knotless Fixation Device: Forward Flexion Angle (12 months) SpeedLock Knotless Fixation Device: Internal Rotation Angle (12 months) SpeedLock Knotless Fixation Device: External Rotation (12 months)
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EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 1 events 1 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 1 events 1 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 1 events 1 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 1 events 1 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 1 events 1 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 1 events 1 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 1 events 1 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 1 events
1 affected
136 at risk
EG004 1 events 1 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 1 events
1 affected
136 at risk
EG004 1 events 1 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 0 events 0 affected 59 at risk
EG006 0 events 0 affected 18 at risk 0 events
0 affected
136 at risk
EG004 0 events 0 affected 57 at risk
EG005 1 events 1 affected 59 at risk
EG006 0 events 0 affected 18 at risk Has full functional arc: Unknown
Has full functional arc: Unknown