FDA Adverse Event
Malfunction
Summary report: N
XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 4.5 X 25
MDR report key: 2891390
·
Received December 21, 2012
Report
- Report Number
- 9617544-2012-00589
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- November 26, 2012
- Report Date
- November 26, 2012
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- KWP
- PMA / PMN Number
- K050461
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE, THIS WILL BE REPORTED AS SUPPLEMENTAL. METHOD, RESULT AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "WHILE TRYING TO LOCK DOWN THE ROD, THE SURGEON CROSS THREAD THE BLOCKING CAP AND STRIPPED THE TULIP HEAD CAUSING IT TO SPLAY AND SPLIT IN HALF ON THE LATERAL SIDE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 4.5 X 25 | IMPLANT | KWP | STRYKER SPINE BORDEAUX | NA | 106254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR |