FDA Adverse Event
Injury
Summary report: N
XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 45 MM
MDR report key: 2051068
·
Received April 5, 2011
Report
- Report Number
- 9617544-2011-00130
- Event Type
- Injury
- Date Received
- April 5, 2011
- Date of Event
- March 18, 2011
- Report Date
- March 18, 2011
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- NKB
- PMA / PMN Number
- K071373
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED AND IF MADE AVAILABLE, WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT "PT HAD INITIAL SURGERY (B)(6), 2008. REVISION SURGERY WAS (B)(6), 2011. WHEN THE RODS AND SET SCREWS WERE REMOVED, THE TULIP HEADS HAD POPPED OFF THE SHANK OF THE SCREW AND RODE DOWN THE SHAFT OF THE SCREW. ALL THE SCREWS HAD TO BE REMOVED AND THE PT NEEDED TO BE REINSTRUMENTED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 45 MM | IMPLANT | NKB | STRYKER SPINE BORDEAUX | NA | A83049 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |