BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I.T.S. GMBH CLAVICAL PLATE

    MDR report key: 3039980 · Received April 2, 2013

    Report

    Report Number
    MW5029605
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    February 8, 2013
    Report Date
    April 2, 2013
    Manufacturer
    I.T.S. GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT RETURNED TO SURGERY FOR REMOVAL OF A BROKEN TITANIUM CLAVICLE FIXATION DEVICE WITH 10 SCREWS AND REPLACEMENT WITH A STAINLESS STEEL CLAVICLE FIXATION DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135349 I.T.S. GMBH CLAVICAL PLATE CLAVICLE FIXATION DEVICE HRS I.T.S. GMBH 21122-10 14709-40

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR