BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETIII SA

    MDR report key: 12014112 · Received June 16, 2021

    Report

    Report Number
    3007135442-2021-00004
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Report Date
    June 15, 2021
    Manufacturer
    HIOSSEN, INC.
    Product Code
    DZE
    PMA / PMN Number
    K140934
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DENTAL IMPLANT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906323 ETIII SA DENTAL IMPLANT DZE HIOSSEN, INC. ET3R4013S H1E14A069

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention