FDA Adverse Event
Injury
Summary report: N
XIA BLOCKER
MDR report key: 2404227
·
Received January 5, 2012
Report
- Report Number
- 9617544-2012-00002
- Event Type
- Injury
- Date Received
- January 5, 2012
- Date of Event
- August 23, 2011
- Report Date
- December 9, 2011
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- KWP
- PMA / PMN Number
- K982494
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL ITEMS RETURNED WITH THIS COMPLAINT: MANTIS CANNULATED POLYAXIAL SCREW 6.5 X 40 MM, CAT # 48285640, LOT #S 080780, 080237, 080779. XIA BLOCKER, CAT # 03756230, LOT #S ACA, YKF, YM7, YNS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT "DR (B)(6) PERFORMED HARDWARE REMOVAL WHICH WAS STRYKER AND NOTICED GREY SCAR TISSUE IN PATIENT, WHICH WAS APPARENTLY CAUSED BY METAL DEBRIS. HE STATED THAT IT APPEARED THAT SCREW CAPS WERE LOOSE. ALL HARDWARE WAS REMOVED L3 TO S1."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XIA BLOCKER | IMPLANT | KWP | STRYKER SPINE BORDEAUX | NA | YKD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |