FDA Adverse Event
Injury
Summary report: N
IMPLANTIUM
MDR report key: 1772001
·
Received July 22, 2010
Report
- Report Number
- 3004578807-2010-00018
- Event Type
- Injury
- Date Received
- July 22, 2010
- Date of Event
- June 8, 2010
- Report Date
- June 25, 2010
- 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, PATIENT BONE CONDITION, PATIENT ORAL HYGIENE, OR PATIENT BEHAVIOR.
Description of Event or Problem · 1
TRADITIONAL 2 STAGE. MODERATE ORAL HYGIENE. MODERATE BONE CONDITION. BONE GRAFTING MATERIAL USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPLANTIUM | ENDOSSEOUS DENTAL IMPLANT | DZE | DENTIUM | MF FX4812 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |