CUSTOM MADE DEVICE MAC PM-TMJ & MODEL
Report
- Report Number
- 0001032347-2018-00347
- Event Type
- Injury
- Date Received
- June 7, 2018
- Date of Event
- May 8, 2018
- Report Date
- November 27, 2018
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- LZD
- PMA / PMN Number
- PN/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
THESE PARTS COULD NOT BE USED IN THE RECONSTRUCTION SURGERY; THEREFORE, THE COMPLAINT IS CONSIDERED CONFIRMED. THE PRODUCT WAS RETURNED WITH THE ORIGINAL PACKAGING. ALL PRODUCT WAS REVIEWED THERE WERE NO VISIBLE ANOMALIES OR DEFECTS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THE DESIGN VENDOR CONDUCTED AN INVESTIGATION INTO THE COMPLAINT; THEIR INVESTIGATION CONCLUDED NO FAILURE MODES WERE IDENTIFIED DURING THE INVESTIGATION OF THIS COMPLAINT. REVIEW OF DIGITAL FILES AND DHR INDICATE THE CASE WAS PROCESSED PER ALL APPLICABLE PROCESSES. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THE SURGEON HAD PREVIOUSLY GIVEN CONSENT TO USE AN SCAN THAT TAKEN GREATER THAN 6 MONTHS PRIOR TO DESIGN. THIS IS A POTENTIAL CONTRIBUTING FACTOR BUT COULD NOT BE CONFIRMED BASED ON THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
DEVICE WAS INADVERTENTLY NOT REPORTED IN THE FINAL MDR (0001032347-2018-00347-1) FOR THE COMPLETION OF THE DEVICE EVALUATION.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
(B)(4). (B)(6). THIS PRODUCT IS MANUFACTURED BY BIOMET MICROFIXATION AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS BIOMET MICROFIXATION MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER PMA NUMBER P020016. THE FOSSA COMPONENTS REMAIN IMPLANTED IN THE PATIENT. CUSTOMER HAS INDICATED THAT THE MANDIBULAR COMPONENTS ARE IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED THE SPLINTS AND MANDIBULAR COMPONENTS DID NOT FIT DURING A CUSTOM BILATERAL TMJ CASE. THE PATIENT WAS ANKYLOSED AND DISLOCATED, BOTH SIDES WERE RELEASED AND PATIENT PLACED IN TEMPORARY CLOSURE. WHEN THE SURGEON WAS READY TO IMPLANT THE JOINTS THE SPLINTS DID NOT FIT AT ALL. THE SURGEON COULD NOT USE THE SPLINTS AND HAD TO WIRE THE PATIENT INTO OCCLUSION WITH NO SPLINTS IN PLACE (I.E. PATIENT WAS WIRED WITH THE UPPER TEETH TO LOWER). BOTH MANDIBLE CUSTOM PROSTHESIS THEN DID NOT FIT, THEREFORE THE SURGEON HAD TO USE STANDARD STOCK 45 MM MANDIBULAR COMPONENTS TO COMPLETE THE CASE. BOTH FOSSA COMPONENTS WERE IMPLANTED WITHOUT ISSUE. THE DELAY IN THE CASE WAS APPROXIMATELY TWO (2) HOURS. THE DAY AFTER THE SURGERY THE SURGEON STATED THE PATIENT IS DOING FINE. DURING A CONFERENCE CALL WITH THE SURGEON FOLLOWING THE CASE HE MENTIONED THE PATIENT'S OCCLUSION MAY HAVE MOVED SLIGHTLY IN THE TIME BETWEEN WHEN THE BITE SPLINTS WERE CREATED TO WHEN THE SURGERY WAS PERFORMED. IN ADDITION, THE STONE MODELS THAT WERE SENT TO THE DESIGN VENDOR WERE GLUED TOGETHER TO SET THE PATIENT'S OCCLUSION. DURING SEPARATION OF THE STONE MODELS, THE TEETH PORTION WAS DAMAGED SLIGHTLY, THEREFORE WHEN THE SCAN WAS TAKEN TO CREATE THE MODELS AND SPLINTS, IT MAY NOT HAVE BEEN COMPLETELY ACCURATE TO PATIENT ANATOMY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 421786 | CUSTOM MADE DEVICE MAC PM-TMJ & MODEL | JOINT, TEMPOROMANDIBULAR, IMPLANT | LZD | BIOMET MICROFIXATION | N/A | 828390 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Hospitalization| R |