BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEMENT RC INICELL, PF 5.0, E 5.0, L9.5

    MDR report key: 19267145 · Received May 8, 2024

    Report

    Report Number
    3003184527-2024-01253
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    April 15, 2024
    Report Date
    April 18, 2024
    Manufacturer
    THOMMEN MEDICAL AG
    Product Code
    DZE
    UDI-DI
    07640156471137
    PMA / PMN Number
    K090154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99661 ELEMENT RC INICELL, PF 5.0, E 5.0, L9.5 DENTAL IMPLANT DZE THOMMEN MEDICAL AG 4.23.143 27969 07640156471137

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other