BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA LP POLYAXIAL SCREW 6.5 X 40MM

    MDR report key: 2278358 · Received September 20, 2011

    Report

    Report Number
    9617544-2011-00320
    Event Type
    Malfunction
    Date Received
    September 20, 2011
    Date of Event
    June 16, 2011
    Report Date
    August 24, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWQ
    PMA / PMN Number
    K002858
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PMA/510(K) # K060361. 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 EVAL.

    Description of Event or Problem · 1

    SHANK OF POLYAXIAL SCREW EMERGED FROM THE NAIL HEAD.

    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 B04780

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK