FDA Adverse Event
Malfunction
Summary report: N
LOCKING SCREW AXSOS 4.0MM / L26MM
MDR report key: 2831500
·
Received October 11, 2012
Report
- Report Number
- 8031020-2012-00251
- Event Type
- Malfunction
- Date Received
- October 11, 2012
- Date of Event
- September 20, 2012
- Report Date
- September 20, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- HRS
- PMA / PMN Number
- K050512
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS DISCARDED BY THE HOSP. ADD'L INFO RECEIVED WILL BE REPORTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, DURING SURGERY THE LOCKING SCREW WAS CONTINUALLY CROSS THREADING. SURGEON WAS UNABLE TO USE IT. HAD TO USE ANOTHER SCREW SAME ITEM. ITEM WAS DISPOSED OF A TIME OF SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LOCKING SCREW AXSOS 4.0MM / L26MM | IMPLANT | HRS | STRYKER OSTEOSYNTHESIS SELZACH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |