BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETIII NH DENTAL IMPLANT

    MDR report key: 9921305 · Received April 3, 2020

    Report

    Report Number
    3007135442-2020-00003
    Event Type
    Malfunction
    Date Received
    April 3, 2020
    Manufacturer
    HIOSSEN, INC.
    Product Code
    DZE
    PMA / PMN Number
    K151626
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DENTAL IMPLANT DID NOT OSSEOINTEGRATE, WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383216 ETIII NH DENTAL IMPLANT DENTAL IMPLANT DZE HIOSSEN, INC. CET3R4008B H1E18I133

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention