BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETIII NH

    MDR report key: 12014111 · Received June 16, 2021

    Report

    Report Number
    3007135442-2021-00005
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    December 1, 2020
    Report Date
    June 16, 2021
    Manufacturer
    HIOSSEN, INC.
    Product Code
    DZE
    PMA / PMN Number
    K151626
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DENTAL IMPLANT FAILED TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906326 ETIII NH DENTAL IMPLANT DZE HIOSSEN, INC. ET3R4511B H1E18H146

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention