BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTIUM

    MDR report key: 1150545 · Received September 3, 2008

    Report

    Report Number
    3004578807-2008-00249
    Event Type
    Injury
    Date Received
    September 3, 2008
    Report Date
    August 8, 2008
    Manufacturer
    DENTIUM
    Product Code
    DZE
    PMA / PMN Number
    K041368
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO OUR INVESTIGATION, THERE WAS NO DISCREPANCY WITH OUR PRODUCT. WE VISITED THE DENTIST ON THE 8TH OF AUGUST, BUT WE WERE NOT ABLE TO OBTAIN ANY ADDITIONAL INFORMATION. (SEE SCANNED PAGES).

    Description of Event or Problem · 1

    THE IMPLANT FAILED DUE TO PATIENT BONE CONDITION. TRADITIONAL 2 STAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTIUM ENDOSSEOUS DENTAL IMPLANT DZE DENTIUM MF FX4308

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention