BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ET SYSTEM

    MDR report key: 9084157 · Received September 18, 2019

    Report

    Report Number
    3007135442-2019-00005
    Event Type
    Malfunction
    Date Received
    September 18, 2019
    Date of Event
    June 13, 2019
    Report Date
    August 30, 2019
    Manufacturer
    HIOSSEN, INC.
    Product Code
    DZE
    PMA / PMN Number
    K140934
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DENTAL IMPLANTS FOUND TO BE FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876904 ET SYSTEM DENTAL IMPLANT DZE HIOSSEN, INC. ET3R4011S H1E13J028

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention