BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEMENT RC INICELL, PF 4.0, E 4.0, L12.5

    MDR report key: 9685889 · Received February 10, 2020

    Report

    Report Number
    3003184527-2020-00330
    Event Type
    Injury
    Date Received
    February 10, 2020
    Date of Event
    January 21, 2020
    Report Date
    February 10, 2020
    Manufacturer
    THOMMEN MEDICAL AG
    Product Code
    DZE
    UDI-DI
    07640156471229
    PMA / PMN Number
    K090154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PRIMARY STABILITY NOT ACHIEVED. AN IMPLANT WITH ANOTHER Ø HAS BEEN PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151060 ELEMENT RC INICELL, PF 4.0, E 4.0, L12.5 DENTAL IMPLANT DZE THOMMEN MEDICAL AG 4.23.125 20235 07640156471229

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other