BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARGON DENTAL IMPLANT

    MDR report key: 2537843 · Received October 1, 2009

    Report

    Report Number
    2085360-2008-00003
    Event Type
    Injury
    Date Received
    October 1, 2009
    Date of Event
    November 18, 2008
    Report Date
    September 29, 2009
    Manufacturer
    BIO-DENT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K961005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PLACED UNDER QUARANTINE.

    Description of Event or Problem · 1

    FAILURE TO INTEGRATE. THIN LAYER OF CORTICAL BONE SURROUNDING MEDIUM-DENSITY SPONGY BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARGON DENTAL IMPLANT 872.3640 DZE BIO-DENT, INC. SARGON IMPLANT 111204

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention