FDA Adverse Event
Death
Summary report: N
BRANEMARK SYSTEM FIXTURE
MDR report key: 12480
·
Received March 4, 1994
Report
- Report Number
- 35133-1994-00228
- Event Type
- Death
- Date Received
- March 4, 1994
- Date of Event
- January 11, 1994
- Report Date
- February 18, 1994
- Manufacturer
- NOBELPHARMA AB
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
FAILURE TO OSSEOINTEGRATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BRANEMARK SYSTEM FIXTURE Implant | DENTAL IMPLANT | DZE | NOBELPHARMA AB | SDCA 064 | 508927 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Death |