BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTIUM

    MDR report key: 3900507 · Received June 27, 2014

    Report

    Report Number
    3005503242-2014-00012
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 8, 2014
    Report Date
    June 27, 2014
    Manufacturer
    DENTIUM USA
    Product Code
    DZE
    PMA / PMN Number
    K041368
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE FIXTURE IN TOOTH LOCATION 7 LOST INTEGRATION AND HAD TO BE REMOVED AFTER OVER 1 YEAR OF IMPLANTATION. THE DOCTOR DID NOT INDICATE ANY CONTRIBUTING FACTORS FOR THE IMPLANT REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377081 IMPLANTIUM ENDOSSEOUS DENTAL IMPLANT DZE DENTIUM USA FX3408MLC G03VA519S

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention