FDA Adverse Event
Other
Summary report: N
IMPLANTIUM
MDR report key: 1003077
·
Received February 22, 2008
Report
- Report Number
- 3004578807-2008-00037
- Event Type
- Other
- Date Received
- February 22, 2008
- Date of Event
- June 8, 2007
- Report Date
- October 11, 2007
- Manufacturer
- DENTIUM CO., LTD.
- Product Code
- DZE
- PMA / PMN Number
- K041368
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
ACCORDING TO OUR INVESTIGATION, THERE WAS NO DISCREPANCY ON OUR PRODUCT. THERE WAS NO INFO ON MEDICAL CONDITION OF PT. SEE SCANNED PAGES.
Description of Event or Problem · 1
THE IMPLANT FAILED DUE TO PT POOR BONE CONDITION. FIXTURE WAS PLACED AT #37 AND REMOVED AFTER 23 MOS. MODERATE ORAL HYGIENE, POOR BONE CONDITION, PROSTHETICS ATTACHMENT (SINGLE).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPLANTIUM | ENDOSSEOUS DENTAL IMPLANT | DZE | DENTIUM CO., LTD. | MF4310 | 05B03-D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention |