BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARGON IMPLANT

    MDR report key: 2853172 · Received July 15, 2008

    Report

    Report Number
    2085360-2008-00002
    Event Type
    Injury
    Date Received
    July 15, 2008
    Date of Event
    June 18, 2008
    Report Date
    July 8, 2008
    Manufacturer
    BIO-DENT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K961005
    Removal / Correction Number
    PR08-0002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION/CONCLUSION: SARGON "EX" "1657". IMPLANT REMAINED MOBILE AND HAS NEVER HEALED. FINALLY, REMOVED AFTER PROPER HEALING. DR (B)(6) WILL REPLACE WITH 13 MM SC IMPLANT.

    Description of Event or Problem · 1

    FAILURE TO HEAL AND INFECTION REQUIRED REMOVAL OF IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARGON IMPLANT 872.3640 DZE BIO-DENT, INC. SARGON IMPLANT 090198

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention