BEUDAMED
    FDA Adverse Event Other Summary report: N

    TSI-OCO BIOMEDICAL INC DENTAL IMPLANT

    MDR report key: 2624051 · Received January 29, 2009

    Report

    Report Number
    1627417-2009-00002
    Event Type
    Other
    Date Received
    January 29, 2009
    Date of Event
    December 1, 2008
    Report Date
    January 28, 2009
    Manufacturer
    OCO BIOMEDICAL, INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT PLACED WITHOUT PRIOR ANTIBIOTICS AND AROUND IMPLANT GREW AN INFECTION AND DRAINING FISTULA. THE CYST WAS REMOVED, BUT THE INFECTION PREVENTED THE IMPLANT FROM INTEGRATING AND CAUSED IMPLANT TO FAIL.

    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 2512

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R