FDA Adverse Event
Other
Summary report: N
IMPLANTIUM
MDR report key: 1002897
·
Received February 22, 2008
Report
- Report Number
- 3004578807-2008-00026
- Event Type
- Other
- Date Received
- February 22, 2008
- Date of Event
- October 2, 2007
- Report Date
- October 15, 2007
- Manufacturer
- DENTIUM CO., LTD.
- Product Code
- DZE
- PMA / PMN Number
- K041368
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ACCORDING TO OUR INVESTIGATION, THERE WAS NO DISCREPANCY ON OUR PRODUCT. THERE IS NO HEALTH INFORMATION ABOUT PATIENT. SEE SCANNED PAGES.
Description of Event or Problem · 1
THE IMPLANT FAILED DUE TO PATIENT'S POOR BONE CONDITION AND INFECTION. INITIAL IMPLANT FAILURE (DID NOT COMPLETE IMPLANTATION). FIXTURE WAS PLACED AT #15 AND REMOVED AFTER 15 DAYS. BONE GRAFT MATERIAL WAS USED. MODERATE ORAL HYGIENE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPLANTIUM | ENDOSSEOUS DENTAL IMPLANT | DZE | DENTIUM CO., LTD. | MF3810 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention |