FDA Adverse Event
Malfunction
Summary report: N
CANCELLOUS SCREW
MDR report key: 1082446
·
Received July 22, 2008
Report
- Report Number
- 8031020-2008-00062
- Event Type
- Malfunction
- Date Received
- July 22, 2008
- Date of Event
- June 27, 2008
- Report Date
- July 8, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- HWC
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED AND IF REC'D, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, WHILE TURNING THE SCREW BECAME HEAVILY DEFORMED. ACCORDING TO THE SURGEON, HE USED TWO FINGERS AND THEN THE SCREW WAS DEFORMED. ANOTHER SCREW WAS USED TO COMPLETE THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CANCELLOUS SCREW | IMPLANT | HWC | STRYKER OSTEOSYNTHESIS SELZACH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |