OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 4/3 X 10MM
Report
- Report Number
- 0001038806-2022-01967
- Event Type
- Injury
- Date Received
- December 26, 2022
- Date of Event
- February 22, 2022
- Report Date
- January 31, 2023
- Manufacturer
- BIOMET 3I
- Product Code
- DZE
- PMA / PMN Number
- K130949
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT: 0002023141-2022- 01965-1, 01969-1, 01965. THIS REPORT IS BEING SUBMITTED TO RELAY CORRECTED DATA. CORRECTED DATA: THE IMPLANT SITE NUMBERS ARE BEING UPDATED WITH SITE #5, 11, 12, AND 2.
MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT: 0001038806-2022-01965, 010001038806-2022-968, 0001038806-2022-01969. ZIMMER BIOMET COMPLAINT NUMBER: (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR INFECTION EVENTS IDENTIFYING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO THE WIDE RANGE OF EXTERNAL (NON-DESIGN/ NON-MANUFACTURING RELATED) FACTORS POTENTIALLY IMPACTING THE STERILITY OF THE IMPLANT AND ITS ENVIRONMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE INFECTION EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.
NO ADDITIONAL EVENT INFORMATION WAS RECEIVED AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT THE IMPLANTS ON TEETH SITES #5, #11, #4 AND #9 WERE REMOVED DUE TO INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2108606 | OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 4/3 X 10MM | DENTAL IMPLANT | DZE | BIOMET 3I | XIITP4310 | 2020090908 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Female | Required Intervention |