BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTIUM

    MDR report key: 1023261 · Received March 31, 2008

    Report

    Report Number
    3004578807-2008-00146
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    December 1, 2007
    Report Date
    February 28, 2008
    Manufacturer
    DENTIUM
    Product Code
    DZE
    PMA / PMN Number
    K041368
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO OUR INVESTIGATION, THERE WAS NO DISCREPANCY ON OUR PRODUCT.

    Description of Event or Problem · 1

    THE IMPLANT FAILED DUE TO POOR BONE CONDITION. THE IMPLANT WAS PLACED AT #32 AND REMOVED AFTER 2 MOS. TRADITIONAL 2 STAGE SURGERY. BONE GRAFT MATERIAL WAS USED. MODERATE ORAL HYGIENE. TOBACCO USE. CARDIAC DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTIUM ENDOSSEOUS DENTAL IMPLANT DZE DENTIUM FX3412

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention BONE GRAFT MATERIAL