FDA Adverse Event
Malfunction
Summary report: N
GUIDE WIRE, BALL-TIPPED, STERILE T2 TIBIA 3X800 M
MDR report key: 2945266
·
Received December 21, 2012
Report
- Report Number
- 9610622-2012-00607
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- December 11, 2012
- Report Date
- December 12, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
IT IS UNKNOWN AT THIS TIME IF THE DEVICES WILL BE AVAILABLE FOR EVALUATION. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IN INCOMING INSPECTION AT DISTRIBUTION, IT WAS FOUND THAT THERE WAS A HAIR IN THE PACKAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUIDE WIRE, BALL-TIPPED, STERILE T2 TIBIA 3X800 M | IMPLANT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | K391149 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |