BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA TITANIUM 4.5 BLOCKER

    MDR report key: 2850675 · Received November 20, 2012

    Report

    Report Number
    9617544-2012-00516
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    MNH
    PMA / PMN Number
    K050461
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    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 CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "ROD PULLED OUT OF THE SCREW, THE BLOCKER SEEMS TO BE SCORED OR MISSING PART OF THE BOTTOM HALF OF IT. THE BLOCKER WAS STILL IN THE SCREWHEAD WHEN WE DID THE REVISION, BUT THE ROD WAS 5-7MM OUT OF THE TULIP HEAD. POST OP FILMS CONFIRM THAT THERE WAS ADEQUATE ROD HANGING OUTSIDE THE TULIP HEAD ONCE IT WAS FINAL TIGHTENED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA TITANIUM 4.5 BLOCKER IMPLANT MNH STRYKER SPINE BORDEAUX NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R