FDA Adverse Event
Malfunction
Summary report: N
IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM
MDR report key: 7969012
·
Received October 16, 2018
Report
- Report Number
- 0002023141-2018-00846
- Event Type
- Malfunction
- Date Received
- October 16, 2018
- Report Date
- October 16, 2018
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- PMA / PMN Number
- PK061410
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ADDITIONAL 510K NUMBER: K013227. DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A HEALING ABUTMENT COULD NOT BE SEATED ON THE IMPLANT (TSVB11) DUE TO INTERNAL THREAD DAMAGE. A THREAD TAP WAS REQUESTED TO RE-THREAD THE IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 808994 | IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM | DENTAL IMPLANT | DZE | ZIMMER DENTAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |