BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOUB SCREW DUAN, 2NN KG 13MM

    MDR report key: 615549 · Received June 3, 2005

    Report

    Report Number
    9615741-2005-00020
    Event Type
    Malfunction
    Date Received
    June 3, 2005
    Report Date
    June 3, 2005
    Manufacturer
    NEWDEAL S.A.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING A SURGERY, THE SPIN SCREW BROKE UNDER THE HEAD WHERE IT WAS IMPLANTED. THE SURGEON REMOVED THE BROKEN SCREW EASILY AND USED ANOTHER SCREW TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOUB SCREW DUAN, 2NN KG 13MM FOREFOOT IMPLANT HWC NEWDEAL S.A. * B257

    Patients

    Seq Age Sex Outcome Treatment
    1 *