BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPLANTIUM

    MDR report key: 1003111 · Received February 22, 2008

    Report

    Report Number
    3004578807-2008-00070
    Event Type
    Other
    Date Received
    February 22, 2008
    Date of Event
    December 22, 2007
    Report Date
    January 2, 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 PRODUCT. THERE IS NO ABOUT MEDICAL CONDITION OF PT. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    THE IMPLANT FAILED DUE TO INFECTION. BONE RECEPTION HAS OCCURRED AROUND THE IMPLANT. THE IMPLANT WAS PLACED AT #26 AND REMOVED AFTER 1 MONTH. TRADITIONAL 2 STAGE SURGERY, MODERATE ORAL HYGIENE, GOOD BONE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTIUM ENDOSSEOUS DENTAL IMPLANT DZE DENTIUM MF4810 06J18-E

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention