BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARGON I.C. WIDE BODY IMPLANT

    MDR report key: 2135754 · Received August 14, 2007

    Report

    Report Number
    2085360-2007-00005
    Event Type
    Injury
    Date Received
    August 14, 2007
    Date of Event
    July 27, 2007
    Report Date
    August 14, 2007
    Manufacturer
    BIO-DENT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K930071
    Removal / Correction Number
    PR07-0005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL/CONCLUSION: DR (B)(6) REPORTS AN IMPLANT (SARGON WBI 13MM) WAS REMOVED ((B)(6) 2007) DUE TO FAILURE TO INTEGRATE. STATED REASON PER (B)(6) WAS; POOR HYGIENE, INSUFFICIENT BONE QUALITY, LISPING TONGUE HABITS. RECOMMENDED: REPLACEMENT N/CHG.

    Description of Event or Problem · 1

    IMPLANT WAS REMOVED DUE TO FAILURE TO INTEGRATE. STATED REASONS AS FOLLOWS: POOR HYGIENE, INSUFFICIENT BONE QUALITY, LISPING HABITS.

    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 031506

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention