BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARGON I.C. STANDARD IMPLANT

    MDR report key: 2594178 · Received November 15, 2010

    Report

    Report Number
    2085360-2010-00001
    Event Type
    Injury
    Date Received
    November 15, 2010
    Date of Event
    August 25, 2010
    Report Date
    October 15, 2010
    Manufacturer
    BIO-DENT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K930071
    Removal / Correction Number
    PR10-0001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    FAILURE TO INTEGRATE. GRANULATED TISSUE IDENTIFIED AROUND THE IMPLANT. PRESENCE OF THICK CORTICAL BONE SURROUNDING SPONGY BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARGON I.C. STANDARD IMPLANT 872.3640 DZE BIO-DENT, INC. SARGON IMPLANT 053008

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention