BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNTHES ATB ANTERIOR LUMBAR INTERBODY LUMBAR TRAY

    MDR report key: 1041338 · Received April 30, 2008

    Report

    Report Number
    1041338
    Event Type
    Malfunction
    Date Received
    April 30, 2008
    Date of Event
    April 28, 2008
    Report Date
    April 30, 2008
    Manufacturer
    SYNTHES USA, INC.
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    SCREW DRIVER TIP BROKE OFF IN HEAD OF SCREW WHILE REMOVING HARDWARE. WE ATTEMPTED TO BUR THE SCREW DRIVER TIP FROM THE HEAD OF THE SCREW UNSUCCESSFULLY; THEN WE USED A SIDE CUTTING BUR TO REMOVE THE PORTION OF PLATE SURROUNDING THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES ATB ANTERIOR LUMBAR INTERBODY LUMBAR TRAY SCREWDRIVER TIP, ORTHOPEDIC HXX SYNTHES USA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR NO OTHER THERAPIES| NO OTHER THERAPIES