BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 728013 · Received June 20, 2006

    Report

    Report Number
    2953769-2006-00032
    Event Type
    Injury
    Date Received
    June 20, 2006
    Date of Event
    May 20, 2006
    Report Date
    May 24, 2006
    Manufacturer
    KYPHON, INC.
    Product Code
    NDN
    PMA / PMN Number
    k033801
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6: METHOD - OTHER: DEVICE NOT RETURNED FOR EVALUATION; FOLLOW-UP CONVERSATION WITH PHYSICIAN REPORTING EVENT. CONCLUSION - OTHER: PARALYSIS WA SNOT DIRECTLY RELATED TO KYPHOPLASTY IN THIS CASE BUT WAS INSTEAD RELATED TO THE FALL. HOWEVER, THE PRESENCE OF BONE CEMENT COULD HAVE CONTRIBUTED TO THE PARALYSIS. THE FILING OF THIS REPORT DOES NOT CONSTITUTUE AN ADMISSION THAT ANY DEVICE DISCUSSED HEREIN CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT. 510(K) # K033801.

    Description of Event or Problem · 1

    AFTER A ONE LEVEL BALLOON KYPHOPLASTY THE PT HAD POSTOPERATIVE LEG WEAKNESS. A CT SCAN WAS PERFORMED AND SHOWED CEMENT IN THE VERTEBRAL BODY WITHOUT EXTRAVASATION. TWO WEEKS LATER, IN THE NURSING HOME, THE PT GOT UP, STUMBLED AND FELL, AFTER WHICH SHE WAS "PARAPLEGIC." A REPEAT CT SCAN SHOWED CEMENT RETROPULSION INTO THE SPINAL CANAL WITH SPINAL CORD SIGNAL CHANGE. AN EMERGENCY SURGERY WAS PERFORMED VIA A POSTERIOR APPROACH. A MOBILE PIECE OF CEMENT WAS FOUND PUSHING ON THE SPINAL CORD. TWO PIECES OF CEMENT TOTAL WERE REMOVED BUT THE PT REMAINS PARALYZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHX HV-R BONE CEMENT HIGH VISCOSITY, RADIOPAQUE BONE CEMENT NDN KYPHON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Disability