FDA Adverse Event
Injury
Summary report: N
IMP AV SBM 3.7MM 4.5MM IN TERFACE 16MM
MDR report key: 15607636
·
Received October 14, 2022
Report
- Report Number
- 0002023141-2022-02597
- Event Type
- Injury
- Date Received
- October 14, 2022
- Date of Event
- July 7, 2022
- Report Date
- February 23, 2023
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- PMA / PMN Number
- K002614
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ADDITIONAL DEVICE INFORMATION UNKNOWN / NOT PROVIDED. PREMARKET IDENTIFICATION K011245. DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED.
Additional Manufacturer Narrative · 0
(B)(4).
Description of Event or Problem · 0
DOCTOR REPORTED THAT DUE TO PERI IMPLANTITIS IMPLANTS LOST INTEGRATION. TOOTH LOCATIONS 33 AND 43. 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 |
|---|---|---|---|---|---|---|---|
| 1888487 | IMP AV SBM 3.7MM 4.5MM IN TERFACE 16MM | DENTAL IMPLANT | DZE | ZIMMER DENTAL | 0510854 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Male | Required Intervention |