BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 PROBE

    MDR report key: 2770204 · Received October 1, 2012

    Report

    Report Number
    9617544-2012-00415
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    September 3, 2012
    Report Date
    September 3, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    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 AN ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    DURING MANTIS SURGERY, THE SURGEON INSERTED THE CANNULATED PROBE IN THE PEDICLE BY THE HAMMER. AND THE SURGEON REMOVED THE INNER SLEEVE. AFTERWARDS, THE SURGEON INSERTED K-WIRE IN THE L5 (LEFT). WHEN THE SURGEON WAS PUSH IN THE CANNULATED PROBE FURTHER, THE TIP OF PROBE WAS BROKEN (ABOUT 3MM). THEREFORE, THE SURGEON REMOVED BROKEN PIECE AND HE CHANGED THE PROBE TO ANOTHER CANNULATED PROBE. THE SURGEON REQUESTED THE INVESTIGATION OF THE PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA 3 PROBE INSTRUMENT NKB STRYKER SPINE BORDEAUX NA 20375

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR