BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAL TAPERED 26X9MM

    MDR report key: 3897144 · Received May 21, 2014

    Report

    Report Number
    3004608878-2014-00060
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    MAX
    PMA / PMN Number
    K082712
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED "ON THE SECOND LEVEL, THE 30X9MM TAPERED TRIAL BROKE INSIDE THE DISC SPACE DURING ROTATION. IT TOOK THE SURGEON AN HOUR AND A HALF TO REMOVE THE TRIAL. THERE WAS NO IDENTICAL SPARE ITEM AVAILABLE BUT THERE WERE ADDITIONAL SIZE OPTIONS USED TO COMPLETE THE CASE". ADDITIONAL INFORMATION WAS REQUESTED BY INTEGRA. ON (B)(6)-2014, THE DISTRIBUTOR SAID THE SURGERY WAS A 2 LEVEL LUMBAR FUSION. THE FRACTURED PIECE OF THE TRIAL WAS REMOVED USING A SURGICAL RONGEUR. THERE WAS NO ADVERSE CONSEQUENCE OR INJURY TO THE PATIENT ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304011 TRIAL TAPERED 26X9MM SPINAL INSTRUMENTS - FIXED MAX INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1