IMP,TSV,MCOL MG,4.7MM,8MM
Report
- Report Number
- 0002023141-2022-00488
- Event Type
- Injury
- Date Received
- February 24, 2022
- Date of Event
- December 20, 2021
- Report Date
- June 21, 2022
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024019812
- PMA / PMN Number
- K111889
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ADDITIONAL 510(K) NUMBER IS K101880.
ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ADDITIONAL 510(K) NUMBER IS K101880.
AFTER FURTHER REVIEW AND ADDITIONAL INFORMATION RECEIVED BY THE CUSTOMER, THE EVENT WAS REASSESSED AND THIS EVENT WOULD NOT RESULT IN A SERIOUS INJURY OR SENTINEL EVENT. AS A RESULT, A RETRACTION WAS SUBMITTED TO THE FDA FOR MFR #0002023141 - 2022 - 00488 AND THE DT WAS REASSESSED AS NOT REPORTABLE. THIS EVENT DID NOT RESULT IN A SERIOUS INJURY AND IS NOT LIKELY TO IF THE EVENT WERE TO RECUR. NO SIGNIFICANT DELAY OR DECLINE IN THE PATIENT'S STATUS DUE TO THE PROCEDURE AND NO ADDITIONAL SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED TO RESOLVE ISSUE. THEREFORE, THIS MALFUNCTION IS DEEMED AS NOT REPORTABLE.
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO FRACTURING WITH AN INFECTION AND PAIN AT THE SITE. PATIENT WILL RETURN FOR A NEW IMPLANT IN THE FUTURE.
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO FRACTURING WITH AN INFECTION AND PAIN AT THE SITE. PATIENT WILL RETURN FOR A NEW IMPLANT IN THE FUTURE.
THE CUSTOMER CLARIFIED THAT THE IMPLANT WAS ACTUALLY REMOVED DUE TO NON INTEGRATION AND NOT DUE TO BECOMING FRACTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1286217 | IMP,TSV,MCOL MG,4.7MM,8MM | DENTAL IMPLANT | DZE | ZIMMER DENTAL | TSVMWB8 | 1246695 | 00889024019812 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Male | Required Intervention |