BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPLANTIUM

    MDR report key: 1003086 · Received February 22, 2008

    Report

    Report Number
    3004578807-2008-00046
    Event Type
    Other
    Date Received
    February 22, 2008
    Report Date
    November 12, 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. THERE IS NO INFO ABOUT MEDICAL CONDITION OF PT.

    Description of Event or Problem · 1

    UNABLE TO OBTAIN THE REASON OF OSSEOINTEGRATION FAILURE FROM THE DOCTOR. TRADITIONAL 2 STAGE, PROSTHETIC ATTACHMENT (BRIDGE), MODERATE ORAL HYGIENE, THE DOCTOR DID NOT PROVIDE THE IMPLANT PLACEMENT DATE AND REMOVAL DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTIUM ENDOSSEOUS DENTAL IMPLANT DZE DENTIUM CO., LTD. MF4808

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention