FDA Adverse Event
Malfunction
Summary report: N
6.5 CANCELLOUS BONE SCREW 35MM
MDR report key: 1163450
·
Received September 10, 2008
Report
- Report Number
- 2249697-2008-00263
- Event Type
- Malfunction
- Date Received
- September 10, 2008
- Date of Event
- August 13, 2008
- Report Date
- August 13, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- HWC
- PMA / PMN Number
- K894124
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. NO EVALUATION WILL BE PERFORMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "UNIVERSAL SCREWDRIVER BROKE IN HEAD OF SCREW. PIECE WAS REMOVED WE PROCEEDED AS USUAL."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6.5 CANCELLOUS BONE SCREW 35MM | IMPLANT | HWC | STRYKER ORTHOPAEDICS MAHWAH | NA | 5W0MRD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Other |