BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPLANTIUM

    MDR report key: 1003118 · Received February 22, 2008

    Report

    Report Number
    3004578807-2008-00085
    Event Type
    Other
    Date Received
    February 22, 2008
    Report Date
    January 21, 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

    WE CAN NOT FILL IN THIS FORM IN DETAIL BECAUSE DR HAVE REFUSED TO OPEN THE PT'S CHART. ACCORDING TO OUR INVESTIGATION, THERE WAS NO DISCREPANCY ON OUR PRODUCT.

    Description of Event or Problem · 1

    THE IMPLANT FAILED DUE TO PT'S POOR BONE CONDITION AND EARLY-LOADING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTIUM ENDOSSEOUS DENTAL IMPLANT DZE DENTIUM MF FX3808

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention