FDA Adverse Event
Injury
Summary report: N
IMPLANTIUM
MDR report key: 1150539
·
Received September 3, 2008
Report
- Report Number
- 3004578807-2008-00251
- Event Type
- Injury
- Date Received
- September 3, 2008
- Date of Event
- July 16, 2008
- Report Date
- August 8, 2008
- Manufacturer
- DENTIUM
- Product Code
- DZE
- PMA / PMN Number
- K041368
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
ACCORDING TO OUR INVESTIGATION, THERE WAS NO DISCREPANCY WITH OUR PRODUCT.
Description of Event or Problem · 1
THE IMPLANT FAILED DUE TO PATIENT BONE CONDITION. THE IMPLANT WAS PLACED AT #36. MODERATE ORAL HYGIENE. TRADITIONAL 2 STAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPLANTIUM | ENDOSSEOUS DENTAL IMPLANT | DZE | DENTIUM | MF FX4810 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |