FDA Adverse Event
Other
Summary report: N
O BUTMENT
MDR report key: 59646
·
Received December 26, 1996
Report
- Report Number
- 1627417-1996-90003
- Event Type
- Other
- Date Received
- December 26, 1996
- Date of Event
- September 24, 1996
- Report Date
- December 18, 1996
- Manufacturer
- "O" CO, INC.
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
IMPLANT WAS PLACED BY DR, YET RESTORED BY ANOTHER DENTIST. CROWN WAS PLACED AND BROKE OFF IN IMPLANT. AFTER REMOVING BROKEN CROWN, DR ACCIENTALLY STRIPPED HE THREADS OF THE IMPLANT. IMPLANT WAS REMOVED AND REPLACED BY ANOTHER IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | O BUTMENT Implant | DENTAL IMPLANT | DZE | "O" CO, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other |