BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMBAR I/F CAGE SYSTEM

    MDR report key: 387293 · Received April 8, 2002

    Report

    Report Number
    1526439-2002-00019
    Event Type
    Other
    Date Received
    April 8, 2002
    Date of Event
    February 1, 2002
    Report Date
    April 8, 2002
    Manufacturer
    DEPUY ACROMED, INC.
    Product Code
    MCV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO DEPUY ACROMED THAT AN EXPLANT SURGERY WAS REQUIRED TO REMOVE A LUMBAR I/F CAGE. ACCORDING TO THE COMPLAINANT, THE PT FELT PAIN A FEW MONTHS POST-OPERATIVELY. SUBSEQUENTLY, THE CAGE WAS REMOVED. THERE WERE NO OTHER ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMBAR I/F CAGE SYSTEM LUMBAR CAGE MCV DEPUY ACROMED, INC. NA K2188

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other