FDA Adverse Event
Injury
Summary report: N
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
MDR report key: 15848471
·
Received November 22, 2022
Report
- Report Number
- 0002023141-2022-02926
- Event Type
- Injury
- Date Received
- November 22, 2022
- Date of Event
- June 29, 2022
- Report Date
- March 14, 2023
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024019608
- PMA / PMN Number
- K061410
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ZIMMER BIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. ADDITIONAL PMA/510(K) NUMBER ¿ K011028 / K013227.
Additional Manufacturer Narrative · 0
(B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE DENTAL IMPLANT FAILED DUE TO FRACTURE IN THE BODY OF THE IMPLANT.
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 |
|---|---|---|---|---|---|---|---|
| 369117 | IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM | DENTAL IMPLANT | DZE | ZIMMER DENTAL | 64069209 | 00889024019608 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Male | Required Intervention |