BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERNAL SCREWDRIVER

    MDR report key: 682288 · Received March 3, 2006

    Report

    Report Number
    9615741-2006-00006
    Event Type
    Malfunction
    Date Received
    March 3, 2006
    Report Date
    March 2, 2006
    Manufacturer
    NEWDEAL S.A.
    Product Code
    KXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A SURERY FOR A 14 YEAR OLD PT WHILE IN FINAL ADJUSTMENT ON THE FIRST KALIX IMPLANT, THE DISTAL FLAT PORTION OF SCREWDRIVER SNAPPED OFF IN THE IMPLANT. THE DR COULD NOT RETRIEVE FROM THE IMPLANT. THE DR CLOSED IT OVER ANYWAY WITH SOFT TISSUE AND DID THE SECOND BILATERAL IMPLANT WITH ANOTHER INSTRUMENT. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *