BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVASIVE COR

    MDR report key: 125295 · Received October 9, 1997

    Report

    Report Number
    MW1012263
    Event Type
    Malfunction
    Date Received
    October 9, 1997
    Date of Event
    September 29, 1997
    Report Date
    September 30, 1997
    Manufacturer
    INNOVASIVE DEVICES, INC.
    Product Code
    GFI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    COR CUTTING DEVICE WAS USED TO HARVEST BONE & CARTILAGE FROM LEFT KNEE TO BE TRANSPLANTED INTO OSTEOCHONDRAL DEFECT. WHEN HARVESTED CORE WAS PLACED IN DEFECT THERE WAS NO BONE GRAFT WITH THE CARTILAGE AS IT WAS DESIGNED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVASIVE COR HARVESTER FOR CARTILAGE BONE GRAFT GFI INNOVASIVE DEVICES, INC. INNOVASIVE COR CUTTER 4MM *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR