BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPLANTIUM

    MDR report key: 1003096 · Received February 22, 2008

    Report

    Report Number
    3004578807-2008-00055
    Event Type
    Other
    Date Received
    February 22, 2008
    Report Date
    November 28, 2007
    Manufacturer
    DENTIUM CO., LTD.
    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

    WE CAN NOT FILL IN THIS FORM IN DETAIL BECAUSE DOCTOR TOLD US THAT HE LOST THE PT'S CHART. ACCORDING TO OUR INVESTIGATION, THERE WAS NO DISCREPANCY ON OUR PRODUCT. CONCLUSION: BASED ON OUR INSPECTION AND TEST RESULTS, THE RETURNED PRODUCT HAS BEEN FOUND TO BE WITHIN SPECIFICATIONS. THEREFORE, THE IMPLANT FAILURE IS MOST LIKELY DUE TO CAUSES OTHER THAN THE PRODUCT SUCH AS SURGICAL MISTAKE, PT BONE CONDITION, PT ORAL HYGIENE, OR PT BEHAVIOR.

    Description of Event or Problem · 1

    INITIAL REPORT STATED THAT OSSEOINTEGRATION DID NOT OCCUR. ON INVESTIGATION, DENTIST SUBSEQUENTLY STATED THAT THE PT BONE CONDITION IS THE CAUSE OF THE IMPLANT FAILURE AND REQUIRED EXPLANTATION. DENTIST UNABLE TO PROVIDE ADD'L INFO RELATIVE TO PRODUCT LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTIUM ENDOSSEOUS DENTAL IMPLANT DZE DENTIUM CO., LTD. MF3812

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention