BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARGON I.C. WIDE BODY IMPLANT

    MDR report key: 2893443 · Received October 14, 2008

    Report

    Report Number
    2085360-2008-00005
    Event Type
    Injury
    Date Received
    October 14, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 29, 2008
    Manufacturer
    BIO-DENT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K930071
    Removal / Correction Number
    PR08-003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION/CONCLUSION: TWO IMPLANTS FAILED TO INTEGRATE: (B)(4) WBI; (B)(4)S. COURTESY REPLACEMENT.

    Description of Event or Problem · 1

    FAILURE TO INTEGRATE. PRESENCE OF THICK CORTICAL BONE SURROUNDING SPONGY BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARGON I.C. WIDE BODY IMPLANT 872.3640 DZE BIO-DENT, INC. SARGON IMPLANT 111006

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention