FDA Adverse Event
Malfunction
Summary report: N
IMPL TAPERED SCR-V MTX 6M M 5.7MM 11.5MM
MDR report key: 12546931
·
Received September 29, 2021
Report
- Report Number
- 0002023141-2021-02707
- Event Type
- Malfunction
- Date Received
- September 29, 2021
- Report Date
- September 29, 2021
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024019386
- PMA / PMN Number
- K061410
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
ZIMMERBIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. PATIENT SEX UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER K013227.
Description of Event or Problem · 1
IT WAS REPORTED THAT DOCTOR RECEIVED THE IMPLANT VIAL AND INSIDE IT THERE WAS NO IMPLANT BUT A HEALING ABUTMENT. DOCTOR WAS ABLE TO FINISH HIS SURGICAL PROCEDURE WITH ANOTHER IMPLANT FROM HIS STOCK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1444352 | IMPL TAPERED SCR-V MTX 6M M 5.7MM 11.5MM | DENTAL IMPLANT | DZE | ZIMMER DENTAL | TSV6B11 | 1216421 | 00889024019386 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |