BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEMENT RC INICELL

    MDR report key: 18249477 · Received December 1, 2023

    Report

    Report Number
    3003708589-2023-00253
    Event Type
    Injury
    Date Received
    December 1, 2023
    Date of Event
    October 12, 2023
    Report Date
    October 16, 2023
    Manufacturer
    THOMMEN MEDICAL AG
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NO IDEA-ADJ IMPLANT WAS AN IMMEDIATE PLACEMENT-INTEGRATED WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399380 ELEMENT RC INICELL DENTAL IMPLANT DZE THOMMEN MEDICAL AG 4.23.132 30437

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male