BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TM ARDIS

    MDR report key: 4196915 · Received October 15, 2014

    Report

    Report Number
    3005751028-2014-00083
    Event Type
    Injury
    Date Received
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    ZIMMER TRABECULAR METAL TECHNOLOGY
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TM ARDIS CAGE POST SURGERY HAD MIGRATED. IT IS UNK IF THERE WAS ANY PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655254 TM ARDIS TM ARDIS NKB ZIMMER TRABECULAR METAL TECHNOLOGY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other