BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA2PA 6.5 SCREW

    MDR report key: 1881943 · Received October 11, 2010

    Report

    Report Number
    9617544-2010-00406
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION OF A PEDIATRIC SCOLIOSIS SURGERY TWO YEARS FROM ORIGINAL SURGERY, IT LOOKED LIKE A POSSIBLE INFECTION. AN XIA2 POLYAXIAL SCREW 6.5 IN DIAMETER WAS REMOVED AFTER REMOVING A BLOCKER AND CUTTING THE ROD. THE SCREW HEAD APPEARED IN A LOCK ANGULATION UNABLE TO LOOSEN WITHOUT GREAT FORCE. ONCE PASSED OFF AND NON STERILE, THE HEAD WAS LOOSED AGAIN WITH A MONODRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA2PA 6.5 SCREW IMPLANT KWQ STRYKER SPINE BORDEAUX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK