BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPLANTIUM

    MDR report key: 1003109 · Received February 22, 2008

    Report

    Report Number
    3004578807-2008-00068
    Event Type
    Other
    Date Received
    February 22, 2008
    Date of Event
    November 14, 2007
    Report Date
    November 22, 2007
    Manufacturer
    DENTIUM CO., LTD.
    Product Code
    DZE
    PMA / PMN Number
    K041368
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE IMPLANT FAILED DUE TO UNK REASON. THE IMPLANT WAS PLACED AT #26 AND REMOVED AFTER 6 MOS. TRADITIONAL 2 STAGE SURGERY, BONE GRAFT MATERIAL WAS USED, HEALING ABUTMENT LOAD, GOOD ORAL HYGIENE, MODERATE BONE CONDITION, TOBACCO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTIUM ENDOSSEOUS DENTAL IMPLANT DZE DENTIUM CO., LTD. MF4312

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention BONE GRAFT MATERIAL