FDA Adverse Event
Malfunction
Summary report: N
XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 45 MM
MDR report key: 2013485
·
Received February 3, 2011
Report
- Report Number
- 9617544-2011-00039
- Event Type
- Malfunction
- Date Received
- February 3, 2011
- Date of Event
- January 7, 2011
- Report Date
- January 7, 2011
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- MNI
- PMA / PMN Number
- K071373
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO 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 "UPON BLOCKER INSERTION, THE TULIP HEAD SPLAYED AND WOULD NOT ACCEPT THE BLOCKER. TRIED 2 SEPARATE BLOCKERS AND SAME RESULT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 45 MM | IMPLANT | MNI | STRYKER SPINE BORDEAUX | NA | B02652 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |