BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARGON IMPLANT

    MDR report key: 2135725 · Received June 19, 2007

    Report

    Report Number
    2085360-2007-00003
    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
    K961005
    Removal / Correction Number
    PR07-0003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL/CONCLUSION: A 10MM STANDARD IMPLANT WAS REPLACED TO DR (B)(6) FOR A REMOVED IMPLANT FROM EDENTULOUS PT. CAUSE OF FAILURE WAS DUE TO NON INTEGRATION OF BONE ON IMPLANT SURFACES.

    Description of Event or Problem · 1

    IMPLANT WAS REMOVED DUE TO NON-INTEGRATION OF BONE ON IMPLANT SURFACE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention