BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARGON I.C. WIDE PROFILE IMPLANT

    MDR report key: 2135741 · Received August 14, 2007

    Report

    Report Number
    2085360-2007-00004
    Event Type
    Injury
    Date Received
    August 14, 2007
    Date of Event
    August 1, 2007
    Report Date
    August 14, 2007
    Manufacturer
    BIO-DENT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K930071
    Removal / Correction Number
    PR07-0004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL/CONCLUSION: IMPLANT ON #5 WAS REMOVED DUE TO INFECTION. PT WAS EVALUATED AS A SMOKER. PLACED ON (B)(6) 2006, AND REMOVED ON (B)(6) 2007 DUE TO NON OSSEO INTEGRATION, DR (B)(6) REMOVED THE IMPLANT AND PERFORMED BONE AUGMENTATION PROCEDURE AND WILL RE-IMPLANT IN 6 MONTHS WITH 13MM I.C SARGON IMPLANT.

    Description of Event or Problem · 1

    IMPLANT WAS REMOVED DUE NON-OSSEOINTEGRATION AS THERE WAS INFECTION; PT WAS EVALUATED AS A SMOKER.

    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 Required Intervention