BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEMENT MC INICELL

    MDR report key: 7503426 · Received May 10, 2018

    Report

    Report Number
    3003708589-2018-00099
    Event Type
    Injury
    Date Received
    May 10, 2018
    Date of Event
    April 18, 2018
    Report Date
    April 20, 2018
    Manufacturer
    THOMMEN MEDICAL AG
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    HOLD - SDA 5/10PAIN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345050 ELEMENT MC INICELL DENTAL IMPLANT DZE THOMMEN MEDICAL AG 4.23.543 16636

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other