BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA II PA ADUSTMENT DRIVER

    MDR report key: 1993628 · Received January 6, 2011

    Report

    Report Number
    9617544-2010-00517
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 "ONE OF THE PRONGS ON THE POLYAXIAL ADJUSTMENT DRIVER BROKE OFF WHILE ADVANCING THE SCREW INTO THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA II PA ADUSTMENT DRIVER INSTRUMENT LXH STRYKER SPINE BORDEAUX NAQ 044936

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR