FDA Adverse Event
Other
Summary report: N
O BUTMENT
MDR report key: 59661
·
Received December 26, 1996
Report
- Report Number
- 1627417-1996-90005
- Event Type
- Other
- Date Received
- December 26, 1996
- Date of Event
- June 20, 1996
- Report Date
- December 18, 1996
- Manufacturer
- "O" CO, INC.
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
PT HAD A COMBINATION OF FACTORS THAT COULD HAVE LEAD TO IMPLANT FAILURE SUCH AS SMOKING, POOR ORAL HYGIENE & HE WORKED IN A TOXIC ENVIRONMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | O BUTMENT Implant | DENTAL IMPLANT | DZE | "O" CO, INC. | TWO IMPLANTS | 1774,1770,1773 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other |