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This study will address medical devices manufactured by Biomet Microfixation (d.b.a. Zimmer Biomet) designed for fixation and stabilization of the facial and mandibular skeleton.
The subject devices are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Facial Plating | Patients undergoing surgical procedures for facial reconstruction for whom Biomet Microfixation titanium plates (or Ti mini plates) were utilized for the repair. |
| |
| Mandibular Plating | Patients undergoing surgical procedures for mandibular reconstruction, including TMJ, for whom Biomet Microfixation titanium plates (or Ti mini plates) were utilized for the repair. |
| |
| HTR-PEKK (midface) | Patients undergoing surgical procedures for midface reconstruction using custom-made prostheses manufactured on PEEK material. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Titanium Facial Plates | Device | The Facial Plating System provides a comprehensive titanium fixation solution for maxillofacial surgery procedures. More than twenty-five different plating options in two systems, the 1.5 mm and 2.0 mm with a variety of instruments, and high torque screws, including meshes, are part of this system. Plates and screws are made of commercially pure titanium per ASTM F-67, Titanium 6Al 4V Alloy per ASTM F-136. |
| Measure | Description | Time Frame |
|---|---|---|
| Survival of implant at 1 year post operative | Frequency and incidence of clinical and radiological adverse events related to the implantation of the subject device leading to removal | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Infection rate at 30 days post operative | Implant site infection rate | 30 days |
| Allergic reaction related to implant material | Clinical and/or pathological assessment of implant allergic reactions leading to removal of the device in the first 2 years post implantation |
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Inclusion Criteria:
Males or females
A patient who underwent one or more of the following surgical procedures completed between January 1, 2015 and December 31, 2019, with plates, screws, and or meshes from the Biomet Microfixation Facial Plating System:
Available follow-up data at least at 30 days' post-operative
Exclusion Criteria:
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Subjects, who underwent a facial, orbital, or midface procedure and received plates, screws and/or mesh manufactured by Biomet Microfixation. All enrolled subjects will provide data from a retrospective chart review on outcomes of interest.
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| Name | Affiliation | Role |
|---|---|---|
| Mark Sun, PhD | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Bernardo Hospital | Salta | Argentina |
This data will support regulatory approval on the subject device. Data from this study will not be made available to other researchers
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|
|
| Titanium Mandibular Plates | Device | The Mandibular Plating System provides a comprehensive titanium fixation solution for mandibular surgical procedures. Several plating options, a variety of instruments, and high torque screws with various plate shapes are part of this system. Plates in the Mandibular Plating System have profiles of various thicknesses. Screws are available in self-tapping, locking and non-locking varieties, and in various sizes between 2.0 mm and 2.3 mm in diameter, and 5 mm to 18 mm in length. |
|
|
| Add-on Condyle | Device | The Add-On Condyle is intended to be implanted in the human jaw to replace the mandibular condyle to functionally reconstruct the temporomandibular joint on a temporary basis for patients undergoing ablative tumor surgery requiring the removal of the native mandibular condyle. This device is not for permanent implantation, traumatic injuries, or for treatment of temporomandibular joint disease. |
|
| HTR-PEKK | Device | The HTR-PEKK implants are fabricated from polyether-ketone-ketone (PEKK) via selective laser sintering (SLS), a 3D manufacturing technique. The laser sintering machine builds the implant in layers as dictated from a stereolithographic (STL) file of the approved implant. The HTR-PEKK implants are designed individually for each patient to replace bony voids in the facial anatomy using a patient's own CT imaging data. The implant is made to fill an existing or planned void (where appropriate) using computer-aided design technology for anatomy enhancement, correction of trauma injuries, and/or to correct congenital defects in the craniofacial bone. |
|
| up to 2 years |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D008337 | Mandibular Fractures |
| D005357 | Fibrous Dysplasia of Bone |
| D009463 | Neuroma |
| D006053 | Goldenhar Syndrome |
| D008342 | Mandibulofacial Dysostosis |
| C537680 | Genee-Wiedemann syndrome |
| C538184 | Acrofacial dysostosis, Nager type |
| ID | Term |
|---|---|
| D007572 | Jaw Fractures |
| D008446 | Maxillofacial Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D003394 | Craniofacial Dysostosis |
| D004413 | Dysostoses |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003103 | Coloboma |
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
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