BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTACK

    MDR report key: 1872506 · Received September 30, 2010

    Report

    Report Number
    1872506
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    August 17, 2010
    Report Date
    September 30, 2010
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROTACK DEVICE BROKE INTO THREE PIECES WHILE BEING USED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTACK FIXATION DEVICE GDW COVIDIEN * P0F0791

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR