BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARDIS INSERTER - 9MM

    MDR report key: 4363759 · Received December 18, 2014

    Report

    Report Number
    2184052-2014-00201
    Event Type
    Malfunction
    Date Received
    December 18, 2014
    Report Date
    December 1, 2014
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    MAX
    PMA / PMN Number
    K131242
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED: DEVICE HISTORY RECORD REVIEW FOR ALL RETURNED DEVICES DID NOT FIND ANY DEFICIENCIES. REVIEW OF INFORMATION PROVIDED AND ANALYSIS OF RETURNED DEVICES CONCLUDED THAT THERE IS NO EVIDENCE OF A PRODUCT DEFECT. THIS IS THE FINAL REPORT THAT WILL BE SUBMITTED ASSOCIATED WITH THIS INCIDENT AND DEVICE. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    SAME CASE AS; 2184052-2014-00200. IT WAS REPORTED THAT A ARDIS CAGE DISSOCIATED FROM THE INSERTER DURING AN IMPLANTATION PROCEDURE. IT WAS ALSO REPORTED THAT THE IMPLANT WAS CROSS THREADED ONTO THE INSERTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835398 ARDIS INSERTER - 9MM ARDIS INSERTER - 9MM MAX ZIMMER SPINE, INC. 3256-02 78ZQ

    Patients

    Seq Age Sex Outcome Treatment
    1