BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETIII NH

    MDR report key: 10014202 · Received April 30, 2020

    Report

    Report Number
    3007135442-2020-00004
    Event Type
    Malfunction
    Date Received
    April 30, 2020
    Report Date
    April 16, 2020
    Manufacturer
    HIOSSEN, INC.
    Product Code
    DZE
    PMA / PMN Number
    K151626
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DENTAL IMPLANT FAILED TO INTEGRATE AND WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476505 ETIII NH DENTAL IMPLANT DZE HIOSSEN, INC. AET3R4008B H1E17E131

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention