FDA Adverse Event
Injury
Summary report: N
BRANEMARK SYSTEM FIXTURE
MDR report key: 15798
·
Received February 25, 1994
Report
- Report Number
- 35133-1994-00178
- Event Type
- Injury
- Date Received
- February 25, 1994
- Date of Event
- November 1, 1993
- Report Date
- February 7, 1994
- Manufacturer
- NOBELPHARMA AB
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
LOSS OF OSSEOINTEGRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BRANEMARK SYSTEM FIXTURE Implant | DENTAL IMPLANT | DZE | NOBELPHARMA AB | SDCA 063 | 507401 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Required Intervention |