BEUDAMED
    FDA Adverse Event Other Summary report: N

    LOW PRESSURE & LOW PROFILE

    MDR report key: 488759 · Received September 17, 2003

    Report

    Report Number
    MW1029656
    Event Type
    Other
    Date Received
    September 17, 2003
    Date of Event
    September 4, 2003
    Report Date
    September 10, 2003
    Manufacturer
    INTERPORE CROSS
    Product Code
    GEA
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING A VERTEBRALPLASTY FOR PAIN MANAGEMENT WHERE BONE CEMENT IS PLACED INTO VETERBRAL BODY TO MAKE IT STRONGER, THEREBY REDUCING THE PAIN. THE CEMENT WAS INJECTED THROUGH THE DEVICE, WHEN THE DEVICE WAS REMOVED, A SMALL PIECE (1/8 INCH) OF THE METAL TIP WAS DISCOVERED MISSING AND BELIEVED TO BE EMBEDDED IN THE CEMENT. IT DID NOT SHOW UP ON X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW PRESSURE & LOW PROFILE VERTEBRALPLASTY SYSTEM GEA INTERPORE CROSS * 207610

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other