BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANYONE 3.5X13 IMPLANT

    MDR report key: 11731619 · Received April 26, 2021

    Report

    Report Number
    MW5100996
    Event Type
    Injury
    Date Received
    April 26, 2021
    Date of Event
    July 1, 2019
    Report Date
    April 22, 2021
    Manufacturer
    MEGAGEN IMPLANT CO., LTD.
    Product Code
    DZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AN X-RAY REVEALED MY IMPLANT HAD FRACTURED. MY PROSTHODONTIST HAD OTHER PATIENTS WITH THE SAME PROBLEM WITH THE SAME IMPLANT. THE FAILED IMPLANT HAD TO BE REMOVED, A BONE GRAPH DONE TO FILL IN THE BONE, AND WAIT FOR HEALING BEFORE ANOTHER IMPLANT TO BE DONE. THE PROCESS TOOK OVER 3 MONTHS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618436 ANYONE 3.5X13 IMPLANT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE MEGAGEN IMPLANT CO., LTD. 150711A0191

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention