FDA Adverse Event
Injury
Summary report: N
IMP TM 4.7MM MTX FULL, 11.5MM
MDR report key: 15864274
·
Received November 25, 2022
Report
- Report Number
- 0002023141-2022-02940
- Event Type
- Injury
- Date Received
- November 25, 2022
- Date of Event
- April 13, 2022
- Report Date
- March 23, 2023
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- PMA / PMN Number
- K132258
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ZIMMERBIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER K113753 AND K112160.
Additional Manufacturer Narrative · 0
(B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT WOULD HAVE TO RETURN TO PLACE A NEW 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 |
|---|---|---|---|---|---|---|---|
| 2687707 | IMP TM 4.7MM MTX FULL, 11.5MM | DENTAL IMPLANT | DZE | ZIMMER DENTAL | 63232556 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Female | Required Intervention |