BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARDIS INSERTER - 9MM

    MDR report key: 4113679 · Received September 17, 2014

    Report

    Report Number
    2184052-2014-00180
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 22, 2014
    Manufacturer
    ZIMMER SPINE
    Product Code
    MAX
    PMA / PMN Number
    K131242
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION CONTAINED HEREIN IS BEING PROVIDED TO THE FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING AND IS BASED ON INFORMATION SUBMITTED BY OTHERS THAT MAY NOT BE FACTUALLY CORRECT. THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OR ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR THAT A DEVICE IS RELATED TO A DEATH OR INJURY.

    Description of Event or Problem · 1

    AN IMPLANT BROKE WHILE BEING IMPLANTED INTO PATIENT. NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575665 ARDIS INSERTER - 9MM ARDIS INSERTER MAX ZIMMER SPINE 3256-02

    Patients

    Seq Age Sex Outcome Treatment
    1