BEUDAMED
    FDA Adverse Event Other Summary report: N

    TSI - OCO BIOMEDICAL INC. DENTAL IMPLANT

    MDR report key: 1038854 · Received May 5, 2008

    Report

    Report Number
    1627417-2008-00002
    Event Type
    Other
    Date Received
    May 5, 2008
    Date of Event
    March 4, 2008
    Report Date
    May 3, 2008
    Manufacturer
    OCO BIOMEDICAL, INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    HEALTH PROFESSIONAL DID NOT RETURN DEVICE FOR EVAL, THEREFORE, NO RESULTS COULD BE TAKEN FROM DEVICE. DR (FOUNDER OF CO) REVIEWED REPORT AND FOUND THAT IMPLANT FAILURE WAS CAUSED BY USER ERROR. IMPLANT DID NOT RECEIVE ADEQUATE TIME TO HEAL.

    Description of Event or Problem · 1

    DENTAL IMPLANT WAS LOOSE 2 WEEKS AFTER PLACEMENT WHEN DR REMOVED IMPLANT. IMPLANT DID NOT OSSEO-INTEGRATE WITHIN TWO WEEKS OF PLACEMENT. OCO BIOMEDICAL CONSIDERS THIS TO BE NORMAL, SINCE MINIMUM AVERAGE HEALING TIME IS 2-3 MONTHS TO OSSEO-INTEGRATE. OCO BIOMEDICAL HAS DETERMINED THE EVENT TO BE CAUSED BY DR ERROR. THE IMPLANT SHOULD HAVE BEEN GIVEN MORE TIME TO HEAL. THERE WAS NO PAIN OR INJURY TO THE PT, HOWEVER, THERE WAS TISSUE INFLAMMATION AROUND THE IMPLANT.

    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 2473

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other