BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERNAL SCREWDRIVER

    MDR report key: 612300 · Received May 27, 2005

    Report

    Report Number
    9615741-2005-00019
    Event Type
    Malfunction
    Date Received
    May 27, 2005
    Report Date
    May 27, 2005
    Manufacturer
    NEWDEAL S.A.
    Product Code
    KXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    INTEGRA REPRESENTATIVE REPORTED FOR THE USER FACILITY THAT THE INTERNAL KALIX DRIVER USED FOR FINAL PLACEMENT OF THE KALIX IMPLANT SNAPPED AT THE TIP OF THE INSTRUMENT. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN TIP AND THE IMPLANT REMAINED IN THE PT DUE TO SUCCESSFUL INSERTION. HOWEVER, IT WAS REPORTED THAT THE IMPLANTED KALIX IMPLANT BACKED OUT OF THE FOOT, REQUIRING A NEW DEVICE TO BE PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERNAL SCREWDRIVER KALIX ASSOCIATED IMPLANT INSTRUMENTS KXX NEWDEAL S.A. * DIT9

    Patients

    Seq Age Sex Outcome Treatment
    1 *