BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARGON I.C. WIDE PROFILE IMPLANT

    MDR report key: 2526526 · Received October 1, 2009

    Report

    Report Number
    2085360-2009-00002
    Event Type
    Injury
    Date Received
    October 1, 2009
    Date of Event
    September 9, 2009
    Report Date
    September 29, 2009
    Manufacturer
    BIO-DENT INC.
    Product Code
    DZE
    PMA / PMN Number
    K930071
    Removal / Correction Number
    PR09-0002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    FAILURE TO INTEGRATE. GRANULATED TISSUE IDENTIFIED AROUND THE IMPLANT, AND THIN LAYER OF CORTICAL BONE SURROUNDING MEDIUM-DENSITY SPONGY BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARGON I.C. WIDE PROFILE IMPLANT 872.3640 DZE BIO-DENT INC. SARGON IMPLANT 031506

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention