BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETIII NH

    MDR report key: 13022291 · Received December 16, 2021

    Report

    Report Number
    3007135224-2021-00010
    Event Type
    Injury
    Date Received
    December 16, 2021
    Report Date
    November 9, 2021
    Manufacturer
    HIOSSEN, INC.
    Product Code
    DZE
    PMA / PMN Number
    K151626
    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 FAILED TO FULLY OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1920063 ETIII NH DENTAL IMPLANT DZE HIOSSEN, INC. ET3R5007B H1E18H149

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention