FDA Adverse Event
Malfunction
Summary report: N
AXIOM REG IMPLANT
MDR report key: 6057535
·
Received October 26, 2016
Report
- Report Number
- 8020776-2016-00011
- Event Type
- Malfunction
- Date Received
- October 26, 2016
- Date of Event
- February 16, 2016
- Report Date
- October 26, 2016
- Manufacturer
- ANTHOGYR
- Product Code
- DZE
- UDI-DI
- 03663394000079
- PMA / PMN Number
- K101913
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
ACCORDING TO THE PRACTITIONER THE IMPLANT DIDN'T TAKE AND FAILED TO INTEGRATE. THE IMPLANT HAS BEEN PLACED IN 43 POSITION ON 11/16/2015. THREE MONTHS LATER AFTER THE IMPLANTATION, THE PRACTITIONER HAS FOUND THAT THE IMPLANT FAILED TO INTEGRATE. NB : COMPLAINT FILE (B)(4) REVIEWED AND REPORTED FURTHER TO OUR FDA INSPECTION THAT TOOK PLACE FROM MAY 30 TO JUNE 2, 2016.
Description of Event or Problem · 1
IMPLANT FAILS TO OSSEOINTEGRATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 709188 | AXIOM REG IMPLANT | IMPLANT AXIOM D3.4 X 12.0 | DZE | ANTHOGYR | OP34120 | 15-042570 | 03663394000079 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |