BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ET NH DENTAL IMPLANT

    MDR report key: 19912043 · Received August 5, 2024

    Report

    Report Number
    3007135442-2024-00010
    Event Type
    Injury
    Date Received
    August 5, 2024
    Report Date
    March 13, 2024
    Manufacturer
    HIOSSEN, INC.
    Product Code
    DZE
    PMA / PMN Number
    K153332
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DENTAL IMPLANT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2293427 ET NH DENTAL IMPLANT DENTAL IMPLANT DZE HIOSSEN, INC. ET3M3010B H1E19G003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention