BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TS III SA

    MDR report key: 22073082 · Received May 22, 2025

    Report

    Report Number
    3003394081-2025-00001
    Event Type
    Injury
    Date Received
    May 22, 2025
    Date of Event
    January 21, 2025
    Report Date
    March 15, 2025
    Manufacturer
    OSSTEM IMPLANT CO., LTD.
    Product Code
    DZE
    PMA / PMN Number
    K222778
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DENTAL IMPLANT FACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219841 TS III SA DENTAL IMPLANT DZE OSSTEM IMPLANT CO., LTD. TS3S4008S FTN20B804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention