BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARGON BI-POLAR IMPLANT

    MDR report key: 2135833 · Received September 11, 2007

    Report

    Report Number
    2085360-2007-00006
    Event Type
    Injury
    Date Received
    September 11, 2007
    Date of Event
    August 14, 2007
    Report Date
    September 6, 2007
    Manufacturer
    BIO-DENT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K961005
    Removal / Correction Number
    PR07-0006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DR (B)(6) REPORTS A FAILURE (AND REMOVAL) OF A 13MM EG B.POLAR AFTER 2 YRS OF SERVICE. (B)(6) SAYS CAUSE OF FAILURE WAS DUE TO POOR HYGIENE AND INFECTION. PLUS "THIN LAYER OF CORTICAL BONE SURROUNDING MEDIUM DENSITY SPONGY BONE.

    Description of Event or Problem · 1

    IMPLANT WAS REMOVED DUE TO POOR HYGIENE AND INFECTION PLUS THIN LAYER OF CORTICAL BONE SURROUNDING MEDIUM DENSITY SPONGY BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARGON BI-POLAR IMPLANT 872.3640 DZE BIO-DENT, INC. BI-POLAR IMPLANT 121002

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention