BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ET SYSTEM

    MDR report key: 9084176 · Received September 18, 2019

    Report

    Report Number
    3007135442-2019-00009
    Event Type
    Malfunction
    Date Received
    September 18, 2019
    Date of Event
    August 2, 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

    BONE LOSS AROUND DENTAL IMPLANT DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877279 ET SYSTEM DENTAL IMPLANT DZE HIOSSEN, INC. ET3R4510S H1E17J013

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R