BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPLANTIUM

    MDR report key: 1003110 · Received February 22, 2008

    Report

    Report Number
    3004578807-2008-00069
    Event Type
    Other
    Date Received
    February 22, 2008
    Date of Event
    December 12, 2007
    Report Date
    December 17, 2007
    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 INFO ABOUT MEDICAL CONDITION OF PT. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    THE IMPLANT FAILED DUE TO PT BONE CONDITION. THE IMPLANT WAS PLACED AT #34 AND REMOVED AFTER 2 MONTHS. FIXTURE WAS PLACED WITH PRIMARY CLOSURE, BONE GRAFT MATERIAL WAS USED. GOOD ORAL HYGIENE. MODERATE BONE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTIUM ENDOSSEOUS DENTAL IMPLANT DZE DENTIUM MF3808 05K18-L

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention BONE GRAFT MATERIAL WAS USED.