BEUDAMED
    FDA Adverse Event Other Summary report: N

    TSI - OCO BIOMEDICAL INC. DENTAL IMPLANT

    MDR report key: 1212781 · Received October 24, 2008

    Report

    Report Number
    1627417-2008-00012
    Event Type
    Other
    Date Received
    October 24, 2008
    Date of Event
    September 10, 2008
    Report Date
    October 24, 2008
    Manufacturer
    OCO BIOMEDICAL, INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DOCTOR REQUESTED IMPLANT TO BE RETURNED FOR LEGAL REASONS. OCO BIOMEDICAL DOES NOT HAVE IMPLANT.

    Description of Event or Problem · 1

    TOP HALF OF IMPLANT SEPARATED FROM BOTTOM HALF OF IMPLANT, BOTTOM HALF INTEGRATED INTO THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSI - OCO BIOMEDICAL INC. DENTAL IMPLANT ENDOSSEOUS DENTAL IMPLANT DZE OCO BIOMEDICAL, INC. TSI 2425

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention