FDA Adverse Event
Malfunction
Summary report: N
LOCKING INSERT AXSOS 5.0MM LOCKING SET
MDR report key: 1981650
·
Received January 12, 2011
Report
- Report Number
- 8031020-2011-00008
- Event Type
- Malfunction
- Date Received
- January 12, 2011
- Date of Event
- December 20, 2010
- Report Date
- December 20, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- HRS
- PMA / PMN Number
- K050512
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE 5.0 LOCKING INSERT WAS NOT IDENTICAL TO OTHER 5.0 LOCKING INSERTS AT THE ACCOUNT. IT WAS REPORTED THAT THE INSERT FIT IN THE AXSOS 5.0 HOLE, BUT WOULD POP OUT AS SOON AS THE LOCKING SCREW WAS PUT IN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LOCKING INSERT AXSOS 5.0MM LOCKING SET | IMPLANT | HRS | STRYKER OSTEOSYNTHESIS SELZACH | NA | W13853 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |