FDA Adverse Event
Malfunction
Summary report: N
XIA II TORQUE WRENCH
MDR report key: 2192732
·
Received July 20, 2011
Report
- Report Number
- 9617544-2011-00251
- Event Type
- Malfunction
- Date Received
- July 20, 2011
- Date of Event
- May 4, 2011
- Report Date
- June 24, 2011
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TH
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION.
Description of Event or Problem · 1
THE TORQUE WRENCH CANNOT TORQUE DURING THE SURGERY BECAUSE IT TURN AROUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XIA II TORQUE WRENCH | INSTRUMENT | LXH | STRYKER SPINE BORDEAUX | NA | 047855 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |