BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEMENT RC INICELL, PF 4.0, E 4.0, L11.0

    MDR report key: 18629376 · Received February 2, 2024

    Report

    Report Number
    3003184527-2024-00347
    Event Type
    Injury
    Date Received
    February 2, 2024
    Date of Event
    November 15, 2023
    Report Date
    January 8, 2024
    Manufacturer
    THOMMEN MEDICAL AG
    Product Code
    DZE
    UDI-DI
    07640156471236
    PMA / PMN Number
    K090154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255572 ELEMENT RC INICELL, PF 4.0, E 4.0, L11.0 DENTAL IMPLANT DZE THOMMEN MEDICAL AG 4.23.124 31077 07640156471236

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Other