FDA Adverse Event
Malfunction
Summary report: N
XIA 3 TITANIUM POLYAXIAL SCREWDRIVER (EVERYTHING B
MDR report key: 2854253
·
Received November 28, 2012
Report
- Report Number
- 9617544-2012-00530
- Event Type
- Malfunction
- Date Received
- November 28, 2012
- Date of Event
- October 29, 2012
- Report Date
- October 31, 2012
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- NKB
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULTS, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.
Description of Event or Problem · 1
(B)(6) NURSE OF THE HOSPITAL REPORTED TO OUR SALES REP THAT SHE WAS OBSERVING A SURGERY PROCEDURE. DURING THIS SHE OBSERVED THAT A PIECE AT THE PROXIMAL END OF THE REPORTED DEVICE HAS BEEN BROKEN OFF. THIS HAPPENED DURING INSERTING THE POLYAXIAL SCREW. THE PIECE COULDN'T BE FOUND. THERE WAS NO DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED AT THE END. NO ADVERSE CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XIA 3 TITANIUM POLYAXIAL SCREWDRIVER (EVERYTHING B | INSTRUMENT | NKB | STRYKER SPINE BORDEAUX | NA | 09D971 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |