FDA Adverse Event
Injury
Summary report: N
TWIST MP-1, 3.75, 13MM
MDR report key: 218162
·
Received April 12, 1999
Report
- Report Number
- 2023141-1999-00178
- Event Type
- Injury
- Date Received
- April 12, 1999
- Date of Event
- March 2, 1999
- Report Date
- April 12, 1999
- Manufacturer
- SULZER CALCITEK
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
DR REPORTED THAT THE IMPLANT FAILED POST RESTORATION. PT IS REPORTEDLY DOING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TWIST MP-1, 3.75, 13MM Implant | TWIST THREADED ENDOSSEOUS IMPLANTS | DZE | SULZER CALCITEK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |