BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM ILIAC SCREWDRIVER

    MDR report key: 2152328 · Received June 23, 2011

    Report

    Report Number
    9617544-2011-00212
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    HXX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL 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 EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "SURGEON ATTEMPTED TO UTILIZE ILIAC SCREWDRIVER (B)(4) TO REMOVE A 8.5 X 80MM XIA 3 ILIAC CLOSED HEAD SCREW, AND UPON APPLYING ROTATIONAL FORCE TO THE SCREWDRIVER, THE TIP SNAPPED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA 3 TITANIUM ILIAC SCREWDRIVER INSTRUMENT HXX STRYKER SPINE BORDEAUX NA 10G638

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK