BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON EXPRESS II INFLATABLE BONE TAMP

    MDR report key: 7568383 · Received June 5, 2018

    Report

    Report Number
    1030489-2018-00797
    Event Type
    Malfunction
    Date Received
    June 5, 2018
    Date of Event
    May 7, 2018
    Report Date
    August 17, 2018
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE IBT RETURNED HAS RADIAL RUPTURE OF THE BALLOON ON THE DISTAL PEAK THAT TRANSVERSES THE FULL CIRCUMFERENCE OF THE BALLOON. THIS IS CAN BE CAUSED BY THE BALLOON COMING IN CONTACT WITH BONE SPLINTERS IN THE VERTEBRAL BODY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # KE152, 510K #K123771 AND UDI# (B)(4) WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERED FROM COMPRESSION FRACTURE AND UNDERWENT BALLOON KYPHOPLASTY(BKP) AT T9-T11. DURING SURGERY, THE BALLOON BURST DURING INFLATION. THE SURGEON FIRST REMOVED SOME FRACTURED BONE WITH CURETTE IN T9 BEFORE BALLOONING. WHILE BALLOONING, THE INFERIOR ENDPLATE BROKE. HE IMMEDIATELY DEFLATED THE BALLOON AND WENT TO LEVEL T11 WHICH HE WANTED TO BALLOON AS WELL WITH THE SAME BALLOON. WHILE INFLATING AT LEVEL T11, THE BALLOON BURST. AS A RESULT, THE SURGEON PERFORMED VERTEBROPLASTY AT T11. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411795 KYPHON EXPRESS II INFLATABLE BONE TAMP ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other