FDA Adverse Event
Malfunction
Summary report: N
LOCKING SCREW AXSOS 4.0MM / L38MM
MDR report key: 2251383
·
Received August 10, 2011
Report
- Report Number
- 8031020-2011-00179
- Event Type
- Malfunction
- Date Received
- August 10, 2011
- Date of Event
- June 20, 2011
- Report Date
- June 20, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- HWC
- PMA / PMN Number
- K050512
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "SURGEON ATTEMPTED TO IMPLANT THE SCREW THROUGH A PLATE IN A LOCKING HOLE. HE COULD NOT GET THE SCREW TO FULLY SEAT SO HE TIGHTENED DOWN VERY HARD WITH THE HAND SCREWDRIVER AND THE HEAD OF THE SCREW SNAPPED OFF."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LOCKING SCREW AXSOS 4.0MM / L38MM | IMPLANT | HWC | STRYKER OSTEOSYNTHESIS SELZACH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Other |