BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA II PA SCREWDRIVER SHAFT

    MDR report key: 1841395 · Received September 10, 2010

    Report

    Report Number
    9617544-2010-00367
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    HXX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "XIA 2 POLYAXIAL INNER SCREWDRIVER SHAFT USED FOR REMOVAL CASES AT TULSA SPINE AND SPECIALTY SUFFERED BROKEN TEETH AND WAS BENT. THE OUTER SHAFT RATCHETING/LOCKING TEETH HAVE BEEN SHEARED OFF AND BOTH ITEMS REQUIRE REPLACEMENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA II PA SCREWDRIVER SHAFT INSTRUMENT HXX STRYKER SPINE BORDEAUX NA 021178

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK