FDA Adverse Event
Malfunction
Summary report: N
SUPER LAG SCREW
MDR report key: 1070412
·
Received June 30, 2008
Report
- Report Number
- 8031020-2008-00047
- Event Type
- Malfunction
- Date Received
- June 30, 2008
- Date of Event
- June 2, 2008
- Report Date
- June 3, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- HWC
- PMA / PMN Number
- K070454
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE REMAINS IMPLANTED. NO EVALUATION WILL BE PERFORMED. IF THE DEVICE OR ADDITIONAL INFO BECOMES AVAILABLE IT WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
DURING THE SURGERY, WHEN THE SURGEON WAS FINISHED SCREWING WITH THE SCREWDRIVER, THE TEETH OF THE ITEM BROKEN. THE SURGEON ALLEGED THAT THE DEVICE BROKE WHEN THE ITEM WAS IMPLANTED COMPLETELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUPER LAG SCREW | IMPLANT | HWC | STRYKER OSTEOSYNTHESIS SELZACH | NA | H16882 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |