BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERNAL SCREWDRIVER

    MDR report key: 596348 · Received April 26, 2005

    Report

    Report Number
    9615741-2005-00007
    Event Type
    Malfunction
    Date Received
    April 26, 2005
    Report Date
    April 26, 2005
    Manufacturer
    NEWDEAL S.A.
    Product Code
    KXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    WHEN THE SURGEON TURNED THE INTERNAL SCREWDRIVER TO EXPAND THE IMPLANT, THE TIP OF THE SCREWDRIVER BROKE OFF INSIDE THE IMPLANT DURING A PROCEDURE. THE IMPLANT WAS THEN REMOVED. ANOTHER IMPLANT COULD NOT BE USED BECAUSE THE SCREWDRIVER WAS BROKEN AND THERE WAS NO OTHER SCREWDRIVER AVAILABLE. THERE WAS NO ADDITIONAL INFO AVAILBLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *