FDA Adverse Event
Malfunction
Summary report: N
WIRE POST
MDR report key: 1070427
·
Received June 30, 2008
Report
- Report Number
- 8031020-2008-00048
- Event Type
- Malfunction
- Date Received
- June 30, 2008
- Date of Event
- June 4, 2008
- Report Date
- June 5, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- HTY
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED, AND IF RECEIVED, WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE SURGEON USED THE WIRE POST IN SURGERY TWICE. AFTER REMOVING THE DEVICE, THE SURGEON FOUND THAT THE FIXING PART OF THE WIRE POST BROKE. THE SURGEON MENTIONED THAT HE DID USE HIGH FORCE TO TIGHTEN THE SCREW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WIRE POST | IMPLANT | HTY | STRYKER OSTEOSYNTHESIS SELZACH | NA | J321132 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |