BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIALTY XIA II SHAFT

    MDR report key: 1841214 · Received September 7, 2010

    Report

    Report Number
    9617544-2010-00344
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 13, 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
    CA, 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 ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "2 PRONGS OF XIA 2 CUSTOM DRIVER BROKE OFF DURING USE IN SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECIALTY XIA II SHAFT INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 2375

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR