BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTIUM

    MDR report key: 1033703 · Received April 25, 2008

    Report

    Report Number
    3004578807-2008-00186
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    April 4, 2008
    Report Date
    April 11, 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 ON OUR PROD.

    Description of Event or Problem · 1

    THE IMPLANT FAILED DUE TO POOR BONE CONDITION AND PT HEALTH HABIT. THE IMPLANT WAS REMOVED AFTER 8 MONTHS. BONE GRAFT MATERIAL WAS USED. POOR ORAL HYGIENE. POOR BONE CONDITION. TOBACCO USE. ALCOHOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTIUM ENDOSSEOUS DENTAL IMPLANT DZE DENTIUM MF FX3812

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention BONE GRAFT MATERIAL WAS USED.