BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARGON INTERNAL CONNECTION IMPLANT

    MDR report key: 2135723 · Received June 19, 2007

    Report

    Report Number
    2085360-2007-00001
    Event Type
    Injury
    Date Received
    June 19, 2007
    Date of Event
    April 23, 2007
    Report Date
    May 31, 2007
    Manufacturer
    BIO-DENT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K930071
    Removal / Correction Number
    PR07-0001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL/CONCLUSION: A 13MM IC IMPLANT WAS REPLACED TO DR (B)(6) FOR A REMOVED IMPLANT FROM #6 TOOTH POSITION. CAUSE OF FAILURE WAS DUE TO NON INTEGRATION OF BONE.

    Description of Event or Problem · 1

    IMPLANT WAS REMOVED DUE TO NON-INTEGRATION OF BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARGON INTERNAL CONNECTION IMPLANT 872.3640 DZE BIO-DENT, INC. SARGON IMPLANT 031506

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention