BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT

    MDR report key: 10836628 · Received November 12, 2020

    Report

    Report Number
    MW5097831
    Event Type
    Injury
    Date Received
    November 12, 2020
    Date of Event
    November 26, 2018
    Report Date
    November 9, 2020
    Manufacturer
    MEGAGEN IMPLANT CO., LTD.
    Product Code
    NHA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD AN IMPLANT PLACED, IT FRACTURED AND DESTROYED SOME OF THE BONE AROUND THE IMPLANT, AND I HAD TO HAVE ANOTHER SURGERY TO REMOVE IMPLANT AND ADD BONE. THIS ALSO WAS CONNECTED TO A BRIDGE THAT HAD TO BE REMOVED AND WILL HAVE TO BE REPLACED. AFTER IT'S HEALED I AM GOING TO HAVE ANOTHER SURGERY TO HAVE ANOTHER IMPLANT PLACED IN THAT POSITION. I WAS NOTIFIED, BY MY DENTIST, THAT I AM NOT THE ONLY PATIENT THAT THIS HAS HAPPENED TO. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298865 IMPLANT ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS NHA MEGAGEN IMPLANT CO., LTD. ANYONE 3.5 150624A0312-01

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other| R