BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETIII SA

    MDR report key: 9152796 · Received October 3, 2019

    Report

    Report Number
    3007135442-2019-00012
    Event Type
    Injury
    Date Received
    October 3, 2019
    Date of Event
    June 28, 2019
    Report Date
    October 3, 2019
    Manufacturer
    HIOSSEN, INC.
    Product Code
    DZE
    PMA / PMN Number
    K140934
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    6 MONTH POST-OP FOUND BONE LOSS AROUND DENTAL IMPLANT, GBR WAS PERFORMED. 1 YEAR POST-OP, ABUTMENT SCREW BROKE AND DENTAL IMPLANT WAS FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946540 ETIII SA DENTAL IMPLANT DZE HIOSSEN, INC. ET3R5010S H1E15K059

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention