FDA Adverse Event
Injury
Summary report: N
STERNGOLD IMPLAMED, FIXTURE, TI,
MDR report key: 149524
·
Received February 16, 1998
Report
- Report Number
- 2921595-1997-00039
- Event Type
- Injury
- Date Received
- February 16, 1998
- Date of Event
- May 15, 1996
- Report Date
- December 17, 1997
- Manufacturer
- STERNGOLD IMPLAMED
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
IMPLANT FAILED TO INTEGRATE. PLACED ON 10/2/1995, REMOVED ON 5/15/1996, AT STAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STERNGOLD IMPLAMED, FIXTURE, TI, Implant | DENTAL IMPLANT | DZE | STERNGOLD IMPLAMED | 901119 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |