BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARDIS PEEK IMPLANT 08X09X22

    MDR report key: 3960664 · Received June 20, 2014

    Report

    Report Number
    2184052-2014-00103
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    MAX
    PMA / PMN Number
    K073202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS: 2184052-2014-00102. IT WAS REPORTED THAT DURING SURGERY THE IMPLANT BROKE. THE SURGEON WAS IMPACTING THE IMPLANT AND IT BROKE. THE SURGEON USED ANOTHER SIZE IMPLANT TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362555 ARDIS PEEK IMPLANT 08X09X22 ARDIS PEEK IMPLANT 08X09X22 MAX ZIMMER SPINE, INC. 3201-080922 2314781

    Patients

    Seq Age Sex Outcome Treatment
    1