OSSEOTITE® TAPERED IMPLANT 5 X 8.5MM
Report
- Report Number
- 0001038806-2021-01174
- Event Type
- Injury
- Date Received
- July 2, 2021
- Date of Event
- March 22, 2021
- Report Date
- December 2, 2021
- Manufacturer
- BIOMET 3I
- Product Code
- DZE
- PMA / PMN Number
- K063286
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
ZIMMER BIOMET COMPLAINT NUMBER: (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. D4: EXPIRATION DATE. G3: DATE RECEIVED BY MANUFACTURER. G6: TYPE OF REPORT. H1: TYPE OF REPORTABLE EVENT. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H6: ADVERSE EVENT PROBLEM. H10: ADDITIONAL NARRATIVE. ONE OSSEOTITE® TAPERED IMPLANT 5 X 8.5MM (NT585) AND ONE UNKNOWN BIOMET ABUTMENT AND ASSOCIATED SCREW WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED THAT THE IMPLANT WAS SEVERELY FRACTURED AND DAMAGED. THERE WAS ALSO BLOOD/BONE RESIDUE AROUND THE EXTERNAL THREADS OF THE IMPLANT. DEVICE HISTORY RECORD (DHR) REVIEW FOR THE LOT: (853048) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMMER BIOMET. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER: (853048) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: FRACTURE: IMPLANT AND FRACTURE) AND NO OTHER COMPLAINT WAS IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENTS WERE CONFIRMED.
ZIMMER BIOMET COMPLAINT NUMBER (B)(4).
ZIMMER BIOMET COMPLAINT NUMBER (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. D6: D6A. IF IMPLANTED. G3: DATE RECEIVED BY MANUFACTURER. G6: TYPE OF REPORT. H1: TYPE OF REPORTABLE EVENT. H2: FOLLOW UP TYPE. H10: ADDITIONAL NARRATIVE.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
ZIMMER BIOMET COMPLAINT (B)(4).
IT WAS REPORTED THAT IMPLANT FRACTURE AT TOOTH LOCATION 15 AND IT WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1002907 | OSSEOTITE® TAPERED IMPLANT 5 X 8.5MM | DENTAL IMPLANT | DZE | BIOMET 3I | 853048 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |