FDA Adverse Event
Injury
Summary report: N
IMPLANTIUM
MDR report key: 1023271
·
Received March 31, 2008
Report
- Report Number
- 3004578807-2008-00136
- Event Type
- Injury
- Date Received
- March 31, 2008
- Date of Event
- February 20, 2008
- Report Date
- February 27, 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 ON OUR PRODUCT. CONCLUSION: BASED ON OUR INSPECTION AND TEST RESULTS, THE RETURNED PRODUCT HAS BEEN FOUND TO BE WITHIN SPECIFICATIONS. THEREFORE, THE IMPLANT FAILURE IS MOST LIKELY DUE TO CAUSES OTHER THAN THE PRODUCT SUCH AS SURGICAL MISTAKE, PT BONE CONDITION, PT ORAL HYGIENE, OR PT BEHAVIOR.
Description of Event or Problem · 1
THE IMPLANT FAILED DUE TO POOR BONE CONDITION. THE IMPLANT WAS REMOVED AFTER 5 MONTHS. TRADITIONAL 2 STAGE SURGERY. MODERATE ORAL HYGIENE. POOR BONE CONDITION. TOBACCO USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPLANTIUM | ENDOSSEOUS DENTAL IMPLANT | DZE | DENTIUM | FX3412 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Required Intervention |