BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEMENT MC INICELL, PF 4,5, E 4,2, L 11,0

    MDR report key: 7905156 · Received September 25, 2018

    Report

    Report Number
    3003184527-2018-00981
    Event Type
    Injury
    Date Received
    September 25, 2018
    Date of Event
    July 23, 2018
    Report Date
    August 9, 2018
    Manufacturer
    THOMMEN MEDICAL AG
    Product Code
    DZE
    UDI-DI
    07640156470116
    PMA / PMN Number
    K093615
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PRIMARY STABILITY AND OSSEOINTEGRATION ACHIEVED. PAIN. SYSTEMATIC DIESEASE: NSF. LOSS OF IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747234 ELEMENT MC INICELL, PF 4,5, E 4,2, L 11,0 DENTAL IMPLANT DZE THOMMEN MEDICAL AG 4.23.534 16850 07640156470116

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other