BEUDAMED
    FDA Adverse Event Summary report: N

    SARGON IMPLANT

    MDR report key: 2254951 · Received April 22, 2008

    Report

    Report Number
    2085360-2008-00001
    Date Received
    April 22, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 22, 2008
    Manufacturer
    BIO-DENT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K961005
    Removal / Correction Number
    PR08-0001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CONCLUSION: DR. (B)(6), REPORTS THAT AFTER PLACING A 12 MM EXTERNAL SARGON IMPLANT ((B)(6) 2008) A FAILURE TO INTEGRATE, REQUIRED REMOVAL. DR. (B)(6) INDICATES HE WILL RE-IMPLANT AFTER USING BONE GRAFTING TECHNIQUES.

    Description of Event or Problem · 1

    FAILURE TO INTEGRATE AND INSUFFICIENT BONE QUALITY 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 050602

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention