BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA TITANIUM 4.5 EXTENDED CONNECTOR SMALL

    MDR report key: 2852405 · Received November 27, 2012

    Report

    Report Number
    9617544-2012-00526
    Event Type
    Injury
    Date Received
    November 27, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 30, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    MNI
    PMA / PMN Number
    K052761
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    ABOUT TWO MONTHS BEFORE, THE PT UNDERWENT THE SURGERY WITH THE SMALL XIA. AFTERWARDS, THE SURGEON CONFIRMED X-RAY. AND HE FOUND THAT THE OFFSET CONNECTOR BROKE. THEREFORE, THE SURGEON REMOVED THE BROKEN CONNECTOR AND THE PT UNDERWENT THE REVISION SURGERY. THE SURGEON REQUESTED THE INVESTIGATION OF THE BROKEN OFFSET CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA TITANIUM 4.5 EXTENDED CONNECTOR SMALL IMPLANT MNI STRYKER SPINE BORDEAUX NA 096062

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R