BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANYONE DENTAL IMPLANT SYSTEM

    MDR report key: 11831325 · Received May 14, 2021

    Report

    Report Number
    MW5101362
    Event Type
    Injury
    Date Received
    May 14, 2021
    Date of Event
    October 20, 2020
    Report Date
    May 12, 2021
    Manufacturer
    MEGAGEN IMPLANT CO., LTD.
    Product Code
    DZE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    CATASTROPHIC VERTICAL FRACTURE OF IMPLANT HEAD, AT ITS WEAKEST POINT-THE APEX OF INTERNAL HEX CONNECTION-AFTER BEING IN FUNCTION FOR A SHORT TIME. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725592 ANYONE DENTAL IMPLANT SYSTEM IMPLANT, ENDOSSEOUS, ROOT-FORM DZE MEGAGEN IMPLANT CO., LTD. ANYONE 3.5 130708A30-01

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Disability