FDA Adverse Event
Malfunction
Summary report: N
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM
MDR report key: 9598259
·
Received January 16, 2020
Report
- Report Number
- 0001038806-2020-00147
- Event Type
- Malfunction
- Date Received
- January 16, 2020
- Date of Event
- October 3, 2019
- Report Date
- January 16, 2020
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- PMA / PMN Number
- K061410
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
ZIMMER BIOMET (B)(4). DATE OF BIRTH UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. CATALOG NUMBER AND LOT NUMBER UNKNOWN / NOT PROVIDED. ADDITIONAL PMA/510(K) NUMBERS: K011028, K013227. DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SCREW BECAME LOOSE. TOOTH LOCATION 30.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 57778 | IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM | SCREW | DZE | ZIMMER DENTAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR |