BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARDIS INSERTER - 9MM

    MDR report key: 3862873 · Received February 19, 2014

    Report

    Report Number
    2184052-2014-00017
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 20, 2014
    Report Date
    January 23, 2014
    Manufacturer
    ZIMMER SPINE
    Product Code
    MAX
    PMA / PMN Number
    K131242
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    SAME CASE AS: 20184052-2014-00018. IT WAS REPORTED THE ARDIS IMPLANT BROKE PERI-OPERATIVELY. THE SURGEON WAS IMPLANTING THE ARDIS 9X9MM IMPLANT AND IT BROKE AT THE POINT WHERE THE IMPLANT CONNECTS TO THE INSERTER. ONLY A SMALL PIECE BROKE OFF THE IMPLANT OF WHICH THE SURGEON WAS ABLE TO RETRIEVE. THE REMAINDER OF THE IMPLANT WAS LEFT IN PLACE IN THE PATIENT AND THE CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104657 ARDIS INSERTER - 9MM ARDIS INSERTER - 9MM MAX ZIMMER SPINE 3256-02 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR