BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROBE HOLDER

    MDR report key: 3003662 · Received February 28, 2013

    Report

    Report Number
    2530088-2013-10182
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    May 26, 2011
    Manufacturer
    SYNTHES (USA) BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    ORACLE IMPLANTATION FOR LUMBER FUSION AT L2-L3. SURGEON WENT TO APPLY THE PROBE HOLDER AND THE DEVICE BROKE AT THE DISTAL END, OFF TO THE PATIENT'S SIDE. ALL BROKEN PIECES WERE RETRIEVED. USED SAME DEVICE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88208 PROBE HOLDER LXH SYNTHES (USA) BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1