Device deficiency is defined as an inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance.

NOTE: Device deficiencies include malfunctions, use errors, and inadequate labelling.

Serious Adverse Event is defined as any adverse event that:

1. Led to a death,

2. Led to serious deterioration in health of the subject that either resulted in:

   1. a life-threatening illness or injury, or
   2. a permanent impairment of a body structure or a body function, or
   3. in-patient or prolonged hospitalization, or
   4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.

3. Led to fetal distress, fetal death or a congenital abnormality or birth defect.

Serious Adverse Event is defined as any adverse event that:

1. Led to a death,

2. Led to serious deterioration in health of the subject that either resulted in:

   1. a life-threatening illness or injury, or
   2. a permanent impairment of a body structure or a body function, or
   3. in-patient or prolonged hospitalization, or
   4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.

3. Led to fetal distress, fetal death or a congenital abnormality or birth defect.

Serious Adverse Event is defined as any adverse event that:

1. Led to a death,

2. Led to serious deterioration in health of the subject that either resulted in:

   1. a life-threatening illness or injury, or
   2. a permanent impairment of a body structure or a body function, or
   3. in-patient or prolonged hospitalization, or
   4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.

3. Led to fetal distress, fetal death or a congenital abnormality or birth defect.

Serious Adverse Event is defined as any adverse event that:

1. Led to a death,

2. Led to serious deterioration in health of the subject that either resulted in:

   1. a life-threatening illness or injury, or
   2. a permanent impairment of a body structure or a body function, or
   3. in-patient or prolonged hospitalization, or
   4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.

3. Led to fetal distress, fetal death or a congenital abnormality or birth defect.

Serious Adverse Event is defined as any adverse event that:

1. Led to a death,

2. Led to serious deterioration in health of the subject that either resulted in:

   1. a life-threatening illness or injury, or
   2. a permanent impairment of a body structure or a body function, or
   3. in-patient or prolonged hospitalization, or
   4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.

3. Led to fetal distress, fetal death or a congenital abnormality or birth defect.

Serious Adverse Event is defined as any adverse event that:

1. Led to a death,

2. Led to serious deterioration in health of the subject that either resulted in:

   1. a life-threatening illness or injury, or
   2. a permanent impairment of a body structure or a body function, or
   3. in-patient or prolonged hospitalization, or
   4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.

3. Led to fetal distress, fetal death or a congenital abnormality or birth defect.

X-ray scoring systems have been implemented according to the medical literature criteria. For trauma defects/arthrodesis, the results are scored using the criteria proposed by Lane and Sandhu (bone formation, union and remodeling) and also including a bone substitute resorption (radiolucency) criteria. As for prosthesis revision/cavity defects, the scoring system includes bone substitute resorption, bone formation, remodeling and presence or absence of a radiolucent line between the bone and the cement/implant. The maximum score for both groups (trauma/arthrodesis & cavity filling/arthroplasty) is 10/10 (excellent consolidation/excellent secondary stabilization) and the minimum score is 0/10 (no consolidation/no secondary stabilization).

X-ray scoring systems have been implemented according to the medical literature criteria. For trauma defects/arthrodesis, the results are scored using the criteria proposed by Lane and Sandhu (bone formation, union and remodeling) and also including a bone substitute resorption (radiolucency) criteria. As for prosthesis revision/cavity defects, the scoring system includes bone substitute resorption, bone formation, remodeling and presence or absence of a radiolucent line between the bone and the cement/implant. The maximum score for both groups (trauma/arthrodesis & cavity filling/arthroplasty) is 10/10 (excellent consolidation/excellent secondary stabilization) and the minimum score is 0/10 (no consolidation/no secondary stabilization).

X-ray scoring systems have been implemented according to the medical literature criteria. For trauma defects/arthrodesis, the results are scored using the criteria proposed by Lane and Sandhu (bone formation, union and remodeling) and also including a bone substitute resorption (radiolucency) criteria. As for prosthesis revision/cavity defects, the scoring system includes bone substitute resorption, bone formation, remodeling and presence or absence of a radiolucent line between the bone and the cement/implant. The maximum score for both groups (trauma/arthrodesis & cavity filling/arthroplasty) is 10/10 (excellent consolidation/excellent secondary stabilization) and the minimum score is 0/10 (no consolidation/no secondary stabilization).

X-ray scoring systems have been implemented according to the medical literature criteria. For trauma defects/arthrodesis, the results are scored using the criteria proposed by Lane and Sandhu (bone formation, union and remodeling) and also including a bone substitute resorption (radiolucency) criteria. As for prosthesis revision/cavity defects, the scoring system includes bone substitute resorption, bone formation, remodeling and presence or absence of a radiolucent line between the bone and the cement/implant. The maximum score for both groups (trauma/arthrodesis & cavity filling/arthroplasty) is 10/10 (excellent consolidation/excellent secondary stabilization) and the minimum score is 0/10 (no consolidation/no secondary stabilization).

X-ray scoring systems have been implemented according to the medical literature criteria. For trauma defects/arthrodesis, the results are scored using the criteria proposed by Lane and Sandhu (bone formation, union and remodeling) and also including a bone substitute resorption (radiolucency) criteria. As for prosthesis revision/cavity defects, the scoring system includes bone substitute resorption, bone formation, remodeling and presence or absence of a radiolucent line between the bone and the cement/implant. The maximum score for both groups (trauma/arthrodesis & cavity filling/arthroplasty) is 10/10 (excellent consolidation/excellent secondary stabilization) and the minimum score is 0/10 (no consolidation/no secondary stabilization).

This health status information is collected before and after a procedure and provides an indication of the clinical outcomes or quality of care delivered to patients. EQ-5D-3L paper questionnaire will be self-administered or it will be administered to patient via a telephone interview. The EQ-5D-5L still consists of 2 parts - the EQ-5D-5L descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 3 levels: no problems, some problems, extreme problems. EQ VAS is a scale on which the "best imaginable health state" is marked 100 and the "worst imaginable state" is marked 0.

This health status information is collected before and after a procedure and provides an indication of the clinical outcomes or quality of care delivered to patients. EQ-5D-3L paper questionnaire will be self-administered or it will be administered to patient via a telephone interview. The EQ-5D-5L still consists of 2 parts - the EQ-5D-5L descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 3 levels: no problems, some problems, extreme problems. EQ VAS is a scale on which the "best imaginable health state" is marked 100 and the "worst imaginable state" is marked 0.

This health status information is collected before and after a procedure and provides an indication of the clinical outcomes or quality of care delivered to patients. EQ-5D-3L paper questionnaire will be self-administered or it will be administered to patient via a telephone interview. The EQ-5D-5L still consists of 2 parts - the EQ-5D-5L descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 3 levels: no problems, some problems, extreme problems. EQ VAS is a scale on which the "best imaginable health state" is marked 100 and the "worst imaginable state" is marked 0.

This health status information is collected before and after a procedure and provides an indication of the clinical outcomes or quality of care delivered to patients. EQ-5D-3L paper questionnaire will be self-administered or it will be administered to patient via a telephone interview. The EQ-5D-5L still consists of 2 parts - the EQ-5D-5L descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 3 levels: no problems, some problems, extreme problems. EQ VAS is a scale on which the "best imaginable health state" is marked 100 and the "worst imaginable state" is marked 0.

This health status information is collected before and after a procedure and provides an indication of the clinical outcomes or quality of care delivered to patients. EQ-5D-3L paper questionnaire will be self-administered or it will be administered to patient via a telephone interview. The EQ-5D-5L still consists of 2 parts - the EQ-5D-5L descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 3 levels: no problems, some problems, extreme problems. EQ VAS is a scale on which the "best imaginable health state" is marked 100 and the "worst imaginable state" is marked 0.

This health status information is collected before and after a procedure and provides an indication of the clinical outcomes or quality of care delivered to patients. EQ-5D-3L paper questionnaire will be self-administered or it will be administered to patient via a telephone interview. The EQ-5D-5L still consists of 2 parts - the EQ-5D-5L descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 3 levels: no problems, some problems, extreme problems. EQ VAS is a scale on which the "best imaginable health state" is marked 100 and the "worst imaginable state" is marked 0.

Functional scores are used to monitor the patient progress. The questionnaires concern the degree of difficulty (level of function) that the patient experienced in performing usual daily activities and higher level activities due to his bone defect. Therefore, the type of functional score depends on the skeletal region impacted by the bone defect:

• Hand/wrist/ elbow/shoulder: Quick-DASH score (Disabilities of Arm, Shoulder & Hand).
• Knee: KOOS-PS (Knee Injury & Osteoarthritis Outcome Score- Physical function Short form)
• Hip: HOOS-PS (Hip disability and Osteoarthritis Outcome Score- Physical function Short form)
• Foot/Ankle: Kitaoka & al's criteria, AOFAS Ankle-Hindfoot Scale; Forefoot Scale; Midfoot scale.

Functional scores are used to monitor the patient progress. The questionnaires concern the degree of difficulty (level of function) that the patient experienced in performing usual daily activities and higher level activities due to his bone defect. Therefore, the type of functional score depends on the skeletal region impacted by the bone defect:

• Hand/wrist/ elbow/shoulder: Quick-DASH score (Disabilities of Arm, Shoulder & Hand).
• Knee: KOOS-PS (Knee Injury & Osteoarthritis Outcome Score- Physical function Short form)
• Hip: HOOS-PS (Hip disability and Osteoarthritis Outcome Score- Physical function Short form)
• Foot/Ankle: Kitaoka & al's criteria, AOFAS Ankle-Hindfoot Scale; Forefoot Scale; Midfoot scale.

Functional scores are used to monitor the patient progress. The questionnaires concern the degree of difficulty (level of function) that the patient experienced in performing usual daily activities and higher level activities due to his bone defect. Therefore, the type of functional score depends on the skeletal region impacted by the bone defect:

• Hand/wrist/ elbow/shoulder: Quick-DASH score (Disabilities of Arm, Shoulder & Hand).
• Knee: KOOS-PS (Knee Injury & Osteoarthritis Outcome Score- Physical function Short form)
• Hip: HOOS-PS (Hip disability and Osteoarthritis Outcome Score- Physical function Short form)
• Foot/Ankle: Kitaoka & al's criteria, AOFAS Ankle-Hindfoot Scale; Forefoot Scale; Midfoot scale.

Functional scores are used to monitor the patient progress. The questionnaires concern the degree of difficulty (level of function) that the patient experienced in performing usual daily activities and higher level activities due to his bone defect. Therefore, the type of functional score depends on the skeletal region impacted by the bone defect:

• Hand/wrist/ elbow/shoulder: Quick-DASH score (Disabilities of Arm, Shoulder & Hand).
• Knee: KOOS-PS (Knee Injury & Osteoarthritis Outcome Score- Physical function Short form)
• Hip: HOOS-PS (Hip disability and Osteoarthritis Outcome Score- Physical function Short form)
• Foot/Ankle: Kitaoka & al's criteria, AOFAS Ankle-Hindfoot Scale; Forefoot Scale; Midfoot scale.

Functional scores are used to monitor the patient progress. The questionnaires concern the degree of difficulty (level of function) that the patient experienced in performing usual daily activities and higher level activities due to his bone defect. Therefore, the type of functional score depends on the skeletal region impacted by the bone defect:

• Hand/wrist/ elbow/shoulder: Quick-DASH score (Disabilities of Arm, Shoulder & Hand).
• Knee: KOOS-PS (Knee Injury & Osteoarthritis Outcome Score- Physical function Short form)
• Hip: HOOS-PS (Hip disability and Osteoarthritis Outcome Score- Physical function Short form)
• Foot/Ankle: Kitaoka & al's criteria, AOFAS Ankle-Hindfoot Scale; Forefoot Scale; Midfoot scale.

Functional scores are used to monitor the patient progress. The questionnaires concern the degree of difficulty (level of function) that the patient experienced in performing usual daily activities and higher level activities due to his bone defect. Therefore, the type of functional score depends on the skeletal region impacted by the bone defect:

• Hand/wrist/ elbow/shoulder: Quick-DASH score (Disabilities of Arm, Shoulder & Hand).
• Knee: KOOS-PS (Knee Injury & Osteoarthritis Outcome Score- Physical function Short form)
• Hip: HOOS-PS (Hip disability and Osteoarthritis Outcome Score- Physical function Short form)
• Foot/Ankle: Kitaoka & al's criteria, AOFAS Ankle-Hindfoot Scale; Forefoot Scale; Midfoot scale.

Surgeon's Satisfaction survey with registry device (about mixing ability, injecting ability and moldability) thanks to a 100-mm Visual Analog Scale (VAS). A score of zero indicated absolutely inacceptable, while a score of 100 indicated very satisfying.