BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON XPANDER II INFLATABLE BONE TAMP

    MDR report key: 4914824 · Received July 8, 2015

    Report

    Report Number
    4914824
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Date of Event
    June 30, 2015
    Report Date
    July 8, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    FEMALE PATIENT UNDERGOING STEREOTACTIC BIOPSY OF T12 WITH BILATERAL KYPHOPLASTY T12: BALLOON SYRINGE IN THE KIT BROKE DURING THE CASE CAUSING THE BALLOON IN THE DEVICE TO BREAK AND RELEASING THE CONTRAST."...USED A HAND DRILL TO DRILL INTO THAT SAME SPOT ON BOTH SIDES AND THEN INSERTED THE KYPHON BALLOON. BOTH WERE INFLATED TO 550, ALMOST 600 POUNDS PER SQUARE INCH AND I GOT SOME CORRECTION OF THE HEIGHT. I DID GET THE SUDDEN LOSS OF PRESSURE ON THE LEFT SIDE AND THE BALLOON HAD BURST AND THERE WAS A LITTLE BIT OF THAT FLUID THAT ESCAPED INTO THE DISK SPACE ABOVE. WE TRIED IRRIGATING THAT OUT AND THAT DID NOT CHANGE MUCH. HOWEVER, AFTER THE BALLOONS WERE REMOVED I THEN USED THE INJECTORS AND I GOT AN EXCELLENT FILL OF CEMENT LEFT TO RIGHT, UP AND DOWN AND FORWARD TO BACKWARD. THE INJECTORS WERE THEN REMOVED AND SHE WAS KEPT STILL FOR 10 MINUTES WHILE THE CEMENT HARDENED. THE STEREOTACTIC REFERENCE ARC WAS THEN REMOVED AND THEN THE WOUNDS WERE CLOSED IN LAYERS USING AN INVERTED INTERRUPTED 2-0 VICRYLS IN THE SUBCUTANEOUS TISSUE AND A RUNNING 4-0 MONOCRYL WAS PLACED IN THE SKIN WHICH WAS DRESSED WITH DERMABOND. THE PATIENT WAS THEN ROTATED ONTO THE STRETCHER, ALLOWED TO AWAKEN, EXTUBATED AND TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441814 KYPHON XPANDER II INFLATABLE BONE TAMP ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK 15/3 KYPHON XPANDER II 0007501960

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR