FDA Adverse Event
Malfunction
Summary report: N
IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM
MDR report key: 9497132
·
Received December 19, 2019
Report
- Report Number
- 0002023141-2019-01330
- Event Type
- Malfunction
- Date Received
- December 19, 2019
- Date of Event
- November 19, 2019
- Report Date
- December 19, 2019
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- PMA / PMN Number
- K061410
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ADDITIONAL PMA/510(K) NUMBER - K011028 / K013227. EMAIL ADDRESS UNKNOWN / NOT PROVIDED.
Description of Event or Problem · 1
TSVB8 DENTAL: FUNCTIONAL: DOES NOT ASSEMBLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1290005 | IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM | DENTAL IMPLANT | DZE | ZIMMER DENTAL | N/A | 1214491 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |