BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARDIS GENERIC

    MDR report key: 4148126 · Received October 2, 2014

    Report

    Report Number
    2184052-2014-00181
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS 3003853072-2014-0031 AND 3003853072-2014-00032. (B)(6) 2011, THE PATIENT RECEIVED AN IMPLANT ON SEGMENT L5/S1 DUE TO OLISTHESIS STAGE 2. A JAVA INSTINCT SYSTEM AND AN ARDIS CAGE WERE IMPLANTED. NO BONE FUSION. THE PATIENT COMPLAINED FOR OVER 6 MONTHS WITH PAIN THAT WAS SPREADING OUT TO THE LEG. A BREAKAGE OF THE 2 PEDICLE SCREWS 6.5 X 40MM IN WK S1 AND DISLOCATION OF THE CAGE WAS NOTICED. ON (B)(6), A REVISION TOOK PLACE, THE SCREW FRAGMENTS WERE REMOVED, NEW RESTORATION WITH TSRH 3D AND IMPLANTATION OF A TMT CAGE HEIGHT 7 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615500 ARDIS GENERIC ARDIS GENERIC KWP ZIMMER SPINE, INC. 3200 ARDIS

    Patients

    Seq Age Sex Outcome Treatment
    1