BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARDIS INSERTER - 9MM

    MDR report key: 3957257 · Received June 17, 2014

    Report

    Report Number
    2184052-2014-00100
    Event Type
    Malfunction
    Date Received
    June 17, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    MAX
    PMA / PMN Number
    K131242
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL RELEVANT INFORMATION WILL BE PROVIDED WHEN THE DEVICE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    SAME AS MDR ID: 2184052-2014-00101. IT WAS REPORTED THAT AN ARDIS PEEK IMPLANT BROKE DURING INSERTION. THE PATIENT WAS UNDERGOING A POSTERIOR LUMBAR FUSION TREATMENT PROCEDURE USING PEDICLE SCREWS AND AN ARDIS PEEK IMPLANT AT LEVELS L5-S1. THE SURGEON PERFORMED PARTIAL FACET REMOVAL, MOBILIZATION OF THE NERVE ROOT, DISC REMOVAL AND PREP. DISTRACTION WAS PERFORMED USING PEDICLE SCREWS AND ARDIS TRIALS. WHILE THE SPACE WAS DISTRACTED, THE ARDIS IMPLANT WAS PLACED AND ADVANCED USING 2-3 IMPACTIONS TO THE INSERTER WHEN IT WAS NOTED THAT A SMALL POSTERIOR PIECE OF THE CAGE HAD BROKEN. THE FRAGMENT WAS REMOVED AND THE REMAINDER OF THE IMPLANT WAS IN THE DISC SPACE, BUT WAS OBVIOUSLY LOOSE AND REMOVED WITH A COKER. UPON REMOVAL, A DIVOT WAS OBSERVED IN THE INFERIOR PART OF L5. THERE WAS A DELAY OF 10 MINUTES AND NO INJURY REPORTED. THE CASE WAS COMPLETED USING POSTERIOLATERAL FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355076 ARDIS INSERTER - 9MM ARDIS INSERTER - 9MM MAX ZIMMER SPINE, INC. 3256-02 28ZR

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR