BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLIF IMPLANT HOLDER

    MDR report key: 2950473 · Received February 5, 2013

    Report

    Report Number
    8030965-2013-10107
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    March 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. LOT NUMBER AND EXPIRATION DATE: THE LOT NUMBER AND THE EXPIRATION DATE COULD NOT BE BRIEFED WITH THE INFORMATION PROVIDED. NO IRREGULARITIES WERE FOUND DURING THE DEVICE HISTORY REVIEW OF THIS PRODUCT. VISUAL INSPECTION SHOWED THAT ONE LEAF SPRING WAS BROKEN. INSTRUMENT CORRESPONDS TO DRAWINGS AND PROCESSES AT THE TIME OF MANUFACTURE. THE SPRING BROKE DUE TO A CORROSION TENSION CRACK (IS OVER 6 YEARS IN OPERATION).

    Description of Event or Problem · 1

    DURING A LUMBAR FUSION PROCEDURE L5-S1, THE SURGEON WAS USING THE PLIF IMPLANT HOLDER AND THE SPRING BROKE OFF. THE PIECE WAS RETRIEVED, AND THE SURGEON CONTINUED WITH THE PROCEDURE. THE SURGEON THEN USED FOUR SCREWDRIVERS FOR TI CLICK-X TO TIGHTEN THE CAPS, AND BENT ALL FOUR TIPS. THE PROCEDURE WAS COMPLETED. THIS COMPLAINT IS ON THE IMPLANT HOLDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47559 PLIF IMPLANT HOLDER LXH SYNTHES GMBH A7OA18

    Patients

    Seq Age Sex Outcome Treatment
    1