BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA LP POLYAXIAL SCREW 6.5 X 40MM

    MDR report key: 1931752 · Received November 22, 2010

    Report

    Report Number
    9617544-2010-00462
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWQ
    PMA / PMN Number
    K060361
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVAL. FIVE BLOCKERS (CAT# 03756230) ARE REFERENCED IN THIS COMPLAINT, HOWEVER, THE SCREW SEEMS TO BE AT THE ROOT CAUSE OF THIS EVENT. INVESTIGATION IS PENDING, REPORTABILITY OF THE BLOCKERS WILL BE RE-EVALUATED ONCE IT IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "BLOCKERS CROSS THREADED MULTIPLE TIMES. SCREW EXCHANGED OUT AND BLOCKER INSERTED SMOOTHLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA LP POLYAXIAL SCREW 6.5 X 40MM IMPLANT KWQ STRYKER SPINE BORDEAUX NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR