BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17669169 · Received September 1, 2023

    Report

    Report Number
    3003184527-2023-01796
    Event Type
    Injury
    Date Received
    September 1, 2023
    Date of Event
    July 25, 2023
    Report Date
    August 22, 2023
    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. (B)(6) ARE THE SAME PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1389451 ELEMENT RC INICELL, PF 4.0, E 4.0, L11.0 DENTAL IMPLANT DZE THOMMEN MEDICAL AG 4.23.124 30610 07640156471236

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Other