FDA Adverse Event
Injury
Summary report: N
XIA TITANIUM 4.5 TA6V LONG ROD DIAM 4.5 X 200
MDR report key: 2842010
·
Received November 14, 2012
Report
- Report Number
- 9617544-2012-00504
- Event Type
- Injury
- Date Received
- November 14, 2012
- Date of Event
- October 10, 2012
- Report Date
- October 18, 2012
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- KWP
- PMA / PMN Number
- K050461
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
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 AN ENGINEERING EVALUATION. ADDITIONAL ITEMS ALSO REFERENCED IN THIS EVENT ARE: CAT 48145040 XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 5.0 X 40 LOT 11C563. CAT 48130000 XIA TITANIUM 4.5 BLOCKER LOTS SET, 5P4, UAV, 2P9.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "REVISION CASE TO REPLACE XIA 4.5 SCREWS WHERE ROD DIS-LODGED ON ONE SIDE AND THE BLOCKERS AND ROD WERE LOOSE ON THE OTHER."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XIA TITANIUM 4.5 TA6V LONG ROD DIAM 4.5 X 200 | IMPLANT | KWP | STRYKER SPINE BORDEAUX | NA | TS2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R |