FDA Adverse Event
Injury
Summary report: N
IMPL TAPERED SP 3.7MM 10M M OCTAGON
MDR report key: 13597870
·
Received February 25, 2022
Report
- Report Number
- 0002023141-2022-00516
- Event Type
- Injury
- Date Received
- February 25, 2022
- Report Date
- August 10, 2022
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- PMA / PMN Number
- K082639
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ZIMMERBIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. DATE OF EVENT UNKNOWN / NOT PROVIDED. FIRST/GIVEN NAME: UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER : K011245 AND K002188.
Additional Manufacturer Narrative · 0
ZIMMERBIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. DATE OF EVENT UNKNOWN / NOT PROVIDED. FIRST/GIVEN NAME: UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER : K011245 AND K002188.
Additional Manufacturer Narrative · 0
(B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT IMPLANT FRACTURED AT THE BODY AFTER 7 YEARS AFTER PLACEMENT. IMPLANT REMOVED AND NEW SURGERY WAS NEEDED TO COMPLETE PROCEDURE.
Description of Event or Problem · 0
IT WAS REPORTED THAT IMPLANT FRACTURED AT THE BODY AFTER 7 YEARS AFTER PLACEMENT. IMPLANT REMOVED AND NEW SURGERY WAS NEEDED TO COMPLETE PROCEDURE.
Description of Event or Problem · 0
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1681397 | IMPL TAPERED SP 3.7MM 10M M OCTAGON | DENTAL IMPLANT | DZE | ZIMMER DENTAL | 61641903 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Male | Required Intervention |