FDA Adverse Event
Malfunction
Summary report: N
XIA 3 TITANIUM BLOCKER
MDR report key: 2002393
·
Received January 28, 2011
Report
- Report Number
- 9617544-2011-00035
- Event Type
- Malfunction
- Date Received
- January 28, 2011
- Date of Event
- January 3, 2011
- Report Date
- January 3, 2011
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- NKB
- PMA / PMN Number
- K071373
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, 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 ENGINEERING EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT "DURING ATTEMPT TO FINAL TIGHTEN BLOCKER. IT WAS DISCOVERED THAT BLOCKER HAD A SPLIT DOWN THE SIDE, IT IS UNKNOWN WHEN OR HOW THIS OCCURRED. THE BLOCKER WAS TOUGH TO REMOVE SINCE INSERTER WOULD SPIN INSIDE BLOCKER, DOCTOR WAS ABLE TO REMOVE BY USING REMOVAL SET AND OTHER INSTRUMENTS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XIA 3 TITANIUM BLOCKER | IMPLANT | NKB | STRYKER SPINE BORDEAUX | NA | U2C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |