BEUDAMED
    FDA Adverse Event Other Summary report: N

    TSI - DENTAL IMPLANT

    MDR report key: 1341295 · Received March 9, 2009

    Report

    Report Number
    1627417-2009-00004
    Event Type
    Other
    Date Received
    March 9, 2009
    Date of Event
    December 1, 2008
    Report Date
    March 9, 2009
    Manufacturer
    OCO BIOMEDICAL, INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPROPER PLACEMENT BY DOCTOR CREATED PRESSURE ON IMPLANT AFTER DELIVERY OF BRIDGE. ROCKING MOTIONS CREATED PRESSURE THAT CAUSED IMPLANT TO BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSI - DENTAL IMPLANT ENDOSSEOUS DENTAL IMPLANT DZE OCO BIOMEDICAL, INC. TSI 2408

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention