BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEEK IMPLANT

    MDR report key: 3788212 · Received April 10, 2014

    Report

    Report Number
    3788212
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    February 19, 2014
    Report Date
    April 10, 2014
    Manufacturer
    SYNTHES (USA) PRODUCTS LLC
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS BROUGHT BACK TO THE OR TO REMOVE THE SYNTHES BONE FLAP AND WASH OUT THE WOUND. THE PATIENT SUFFERED FROM AN INFECTION ON RIGHT SIDE OF BONE FLAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216909 PEEK IMPLANT IMPLANT, BONE FLAP MAX SYNTHES (USA) PRODUCTS LLC SD800441 7569991

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR