BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETIII

    MDR report key: 9444918 · Received December 10, 2019

    Report

    Report Number
    3007135442-2019-00014
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    June 6, 2019
    Report Date
    December 10, 2019
    Manufacturer
    HIOSSEN, INC.
    Product Code
    DZE
    PMA / PMN Number
    K140934
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HAD A DENTAL IMPLANT PLACE 4 YEARS AGO. THE ABUTMENT BECAME LOSE AND UPON RADIOGRAPHIC EVALUATION, BONE LOSS AND FIXTURE FRACTURE WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237902 ETIII DENTAL IMPLANT DZE HIOSSEN, INC. ET3M3513S H1E13L010

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention