BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISD-OCO BIOMEDICAL INC. DENTAL IMPLANT

    MDR report key: 1181683 · Received September 30, 2008

    Report

    Report Number
    1627417-2008-00010
    Event Type
    Other
    Date Received
    September 30, 2008
    Date of Event
    April 21, 2008
    Report Date
    September 29, 2008
    Manufacturer
    OCO BIOMEDICAL, INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISD IMPLANT WAS SOLD FOR TEMPORARY USE AND SOLD NON-STERILE. (B) (4) EVALUATED FAILED IMPLANT AND DETERMINED THE IMPLANT WAS TORQUED TOO STRONGLY, ABOVE THE RECOMMENDED AMOUNT. THERE WAS NO SIGN OF ANY MFG DEFECTS.

    Description of Event or Problem · 1

    DENTAL IMPLANT BROKE IN PT'S MOUTH. THE BREAK WAS IN THE MIDDLE OF THE THREADED PART OF THE IMPLANT ABOUT 6MM FROM THE BOTTOM. UPON BREAKING, THE TOP PART WAS EASILY REMOVED, HOWEVER, THE BOTTOM HALF HAD INTEGRATED INTO THE BONE, AND HAD TO BE REMOVED BY THE DR. NO SERIOUS INJURY WAS CAUSED. DR REPLACED THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISD-OCO BIOMEDICAL INC. DENTAL IMPLANT ENDOSSEOUS DENTAL IMPLANT DZE OCO BIOMEDICAL, INC. ISD BG613

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention