BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL IMPLANT INSERTER

    MDR report key: 744387 · Received June 24, 2005

    Report

    Report Number
    2247737-2005-00007
    Event Type
    Malfunction
    Date Received
    June 24, 2005
    Date of Event
    May 18, 2005
    Report Date
    June 24, 2005
    Manufacturer
    ZIMMER TMT
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H.6 - WITH REGARDS TO THE DEVICE, THE INTERFACE BETWEEN THE DEVICE AND INSTRUMENT CANNOT BE ANALYZED DUE TO THE NATURE OF THE EVENT. NO OTHER REPORTS OF THIS TYPE HAVE BEEN PREVIOUSLY REPORTED, THEREFORE, THIS BEING CONSIDERED AN ISOLATED INCIDENT. WITH REGARDS TO THE INSTRUMENT, AN IMPROVEMENT HAS ALREADY BEEN IMPLEMENTED INTO THE THE DESIGN OF THE THREADED CLAMPING MECHANISM.

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO IMPLANT A TM-400 DEVICE, THE INSTRUMENT DISENGAGED AND SHEARD OFF A SMALL PORTION OF THE DEVICE. WHILE INSERTING A SECOND IMPLANT, THE INSTRUMENT'S THREADED CLAMPING MECHANISM BROKE, DISENGAGING IT FROM THE DEVICE. THE DEVICE WAS FULLY POSITIONED WITH A SECOND INSTRUMENT AND TAMPED INTO PLACE. THE PORTION OF TH FIRST IMPLANT, WHICH SHEARD OFF, WAS REMOVED FROM THE SITE AND THE SURGERY WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL IMPLANT INSERTER INSERTER HWA ZIMMER TMT * 774811

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN