BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEMENT RC INICELL, PF 5,0, E 5,0, L 9,5

    MDR report key: 7563676 · Received June 2, 2018

    Report

    Report Number
    3003184527-2018-00537
    Event Type
    Injury
    Date Received
    June 2, 2018
    Date of Event
    May 23, 2018
    Report Date
    May 24, 2018
    Manufacturer
    THOMMEN MEDICAL AG
    Product Code
    DZE
    UDI-DI
    07640156471137
    PMA / PMN Number
    K090154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    NO PRIMARY STABILITY ACHIEVED. INSTEAD OF THIS IMPLANT ANOTHER ONW WITH 8MM LENGTH WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406058 ELEMENT RC INICELL, PF 5,0, E 5,0, L 9,5 DENTAL IMPLANT DZE THOMMEN MEDICAL AG 4.23.143 16541 07640156471137

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other