BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPLANTIUM

    MDR report key: 1003113 · Received February 22, 2008

    Report

    Report Number
    3004578807-2008-00072
    Event Type
    Other
    Date Received
    February 22, 2008
    Date of Event
    December 26, 2007
    Report Date
    December 26, 2007
    Manufacturer
    DENTIUM
    Product Code
    DZE
    PMA / PMN Number
    K041368
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO OUR INVESTIGATION, THERE WAS NO DISCREPANCY ON OUR PRODUCT. THERE IS NO INFORMATION ABOUT MEDICAL CONDITION OF PT.

    Description of Event or Problem · 1

    THE IMPLANT FAILED DUE TO UNKNOWN REASON. THE IMPLANT WAS PLACED AT #15 AND REMOVED AFTER 1 YEAR. ONE STAGE SURGERY, GOOD ORAL HYGIENE, GOOD BONE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTIUM ENDOSSEOUS DENTAL IMPLANT DZE DENTIUM MF4310 05J18-D

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention