BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM BLOCKER

    MDR report key: 2844337 · Received November 8, 2012

    Report

    Report Number
    9617544-2012-00491
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 AN ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    DR. (B)(6) HAD PLACED THE RODS INTO THE TULIP HEADS OF THE PEDICEL SCREWS AND PROVISIONALLY TIGHTENED. HE THEN USED THE SMALL DISTRACTOR ON THE ROD BETWEEN SCREWS TO DISTRACT. WHEN THE DESIRED DISTRACTION WAS ACHIEVED, HE USED THE UNIVERSAL TIGHTENER TO TIGHTEN THE BLOCKER IN ONE OF THE SCREWS TO HOLD DISTRACTION. WHEN DOING SO, THE SURGEON REPORTED THE TULIP HEAD OF THE SCREW SPLAYING OPEN WHILE HE WAS TIGHTENING THE BLOCKER. THE DISTRACTION WAS NOT HELD BY THE BLOCKER, SO HE REMOVED THE BLOCKER, REPLACED IT AND REPEATED THE TECHNIQUE OF DISTRACTION AND TIGHTENING THE BLOCKER. THE BLOCKER DID HOLD, AND THE DECOMPRESSION AND TLIF TECHNIQUES WERE PERFORMED ROUTINELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA 3 TITANIUM BLOCKER IMPLANT KWP STRYKER SPINE BORDEAUX NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK