BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEMENT MC INICELL

    MDR report key: 22922316 · Received August 29, 2025

    Report

    Report Number
    3003708589-2025-00209
    Event Type
    Injury
    Date Received
    August 29, 2025
    Date of Event
    August 4, 2025
    Report Date
    July 31, 2025
    Manufacturer
    THOMMEN MEDICAL AG
    Product Code
    DZS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INADEQUATE BONE, BONE RESORPTION, PERI-IMPLANTITIS, MOBILITY, INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2221599 ELEMENT MC INICELL DENTAL IMPLANT DZS THOMMEN MEDICAL AG 4.23.513 23754

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Other