FDA Adverse Event
Malfunction
Summary report: N
XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 40 MM
MDR report key: 1921090
·
Received November 11, 2010
Report
- Report Number
- 9617544-2010-00455
- Event Type
- Malfunction
- Date Received
- November 11, 2010
- Date of Event
- October 29, 2010
- Report Date
- October 29, 2010
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- MNI
- PMA / PMN Number
- K071373
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 ENGINEERING EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT "THE TULIP HEAD OF A XIA 3 SCREW (7.5 X 40) POPPED OFF WHILE THE SURGEON WAS USING A COBB TO MOVE TISSUE AWAY FROM THE SCREW."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 40 MM | IMPLANT | MNI | STRYKER SPINE BORDEAUX | NA | A82968 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |