FDA Adverse Event
Injury
Summary report: N
IMPLANTIUM
MDR report key: 1820639
·
Received August 26, 2010
Report
- Report Number
- 3005503242-2010-00077
- Event Type
- Injury
- Date Received
- August 26, 2010
- Date of Event
- August 3, 2010
- Report Date
- August 6, 2010
- Manufacturer
- DENTIUM USA
- Product Code
- DZE
- PMA / PMN Number
- K041368
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: BASED ON INSPECTION AND TEST RESULTS, THE RETURNED PRODUCT HAS BEEN FOUND TO BE WITHIN SPECIFICATION. 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
PRODUCT WAS RETURNED AS AN IMPLANT FAILURE BECAUSE OF LACK OF INTEGRATION. BASED ON THE REPORT, THE PT HAD MODERATE ORAL HYGIENE AND MODERATE BONE CONDITION. THE FIXTURE WAS PLACED WITH A TRADITIONAL 2 STAGE SURGERY IN TOOTH LOCATION #9. NO BONE MATERIAL WAS USED. THE DOCTOR INDICATED THAT THE DEVICE WAS NOT RECEIVED DAMAGED OR DEFECTIVE SUCH THAT IT WOULD NOT PERFORM AS INTENDED. THE PT'S OUTCOME WAS REPORTED AS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPLANTIUM | ENDOSSEOUS DENTAL IMPLANT | DZE | DENTIUM USA | FX3810MLC | 08B0601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |