CUSTOM MADE DEVICE UPADHYAYA LEFT PM-TMJ & MODEL
Report
- Report Number
- 0001032347-2019-00171
- Event Type
- Injury
- Date Received
- March 18, 2019
- Report Date
- August 30, 2019
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- LZD
- PMA / PMN Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. BASED ON THE VENDOR COMPLAINT REPORT, IT WAS DETERMINED THAT THE ORTHOGNATHIC MOVEMENTS DID NOT MATCH THE VSP, THE COMPLAINT IS CONFIRMED. THEY PROPOSED THIS WAS DUE TO THE LEFORT OSTEOTOMY OF THE MAXILLA ON THE POSTOP SCAN DIFFERING FROM THE PLANNED ONE. NO X-RAYS, SCANS, PHOTOGRAPHS, OR PHYSICIAN REPORTS WERE PROVIDED. THE PRODUCT WAS NOT RETURNED AND NO FUNCTIONAL TESTS OR INSPECTIONS COULD BE PERFORMED. THE DESIGN VENDOR REVIEWED THE DIGITAL DESIGN OF THE LEFT FOSSA AND MANDIBLE IMPLANTS AND MARKING GUIDES AND DETERMINED THAT THEY FIT CORRECTLY TO THE PATIENT'S ANATOMY, THE SCREW HOLE LOCATIONS WERE CORRECT, AND THE PRODUCTS WERE THEREFORE CONFORMING TO DESIGN SPECIFICATIONS (470-500). THE DHRS FOR THE COMPONENTS FOR TMJPM-1944 (CP754430, CP754431 & CP754432) WERE REVIEWED AND TWO NCS WERE FOUND, THOUGH THE PARTS WERE RELEASED AND DEEMED ACCEPTABLE. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. HOWEVER, IT IS POSSIBLE THAT THIS MAY HAVE BEEN DUE TO LEFORT MARKING GUIDES NOT HAVING BEEN REQUESTED/PROVIDED. INTERMEDIATE AND FINAL SPLINTS WERE PROVIDED, AND A DIGITAL REVIEW BY THE VENDOR FOUND THEM TO BE CONFORMING TO WI 470-906. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DESCRIBE EVENT OR PROBLEM, IF IMPLANTED, GIVE DATE, MEDICAL DEVICE - BIOMET MICROFIXATION SCREW, CATALOG #: 91-2714, LOT #: UNKNOWN; BIOMET MICROFIXATION SCREW, CATALOG #: 91-2716, LOT #: UNKNOWN; BIOMET MICROFIXATION SCREW, CATALOG #: 91-2718, LOT #: UNKNOWN. ESTABLISHMENT NAME, ADDRESS - LINE 1, POST OFFICE OR ZIP CODE, DATE RECEIVED BY MANUFACTURER, TYPE OF REPORT, FOLLOW UP TYPE. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2019-00221, 0001032347-2019-00222 & 0001032347-2019-00223.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
THE REVISION IS PLANNED BECAUSE THE MANDIBLE COMPONENT HAS BECOME DISLOCATED FROM THE FOSSA COMPONENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
ZIMMER BIOMET COMPLAINT (B)(4). THE PART AND LOT NUMBERS OF THE SCREWS ARE UNKNOWN AT THIS TIME, IF THIS INFORMATION IS RECEIVED ADDITIONAL REPORTS WILL BE SUBMITTED. REPORT SOURCE: FOREIGN COUNTRY: (B)(6). PMA/510(K) NUMBER: THIS PRODUCT 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 U.S. UNDER PMA NUMBER P020016. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED A REQUEST FOR A CUSTOM IMPLANT WAS RECEIVED, INDICATING THAT A REVISION WILL OCCUR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 222643 | CUSTOM MADE DEVICE UPADHYAYA LEFT PM-TMJ & MODEL | CUSTOM MADE TMJ | LZD | BIOMET MICROFIXATION | N/A | 812610 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |