BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON® EXPRESS¿ INFLATABLE BONE TAMP

    MDR report key: 6019963 · Received October 12, 2016

    Report

    Report Number
    2953769-2016-00080
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Date of Event
    September 13, 2016
    Report Date
    October 20, 2016
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA 510(K): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # KE-152, 510K # K123771 WAS CLEARED IN THE UNITED STATES. PRODUCT ANALYSIS: DURING FUNCTIONAL ANALYSIS IT WAS NOT POSSIBLE TO INFLATE THE IBT DUE TO A LEAK. VISUAL ANALYSIS CONFIRMED THE PRESENCE OF LONGITUDINAL RUPTURE NEAR THE PROXIMAL PEAK. CONCLUSION: BASED ON THE INFORMATION PROVIDED, FUNCTIONAL AND VISUAL ANALYSIS, THE MOST PROBABLE ROOT CAUSE OF THE RUPTURE OF THE BALLOON IS ATTRIBUTED TO CONTACT WITH BONE SPLINTERS DURING SURGERY. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    NO FRAGMENTS OF THE BALLOON REMAINED INSIDE THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016, PATIENT UNDERWENT BALLOON KYPHOPLASTY AT T12. INTRA-OP, THE BALLOON RUPTURED WHILE THE SURGEON WAS INJECTING THE CEMENT IN THE OPPOSITE WORKING CANNULA. A BI-PORTAL ACCESS WITH TWO BALLOONS WAS PERFORMED. SURGEON INFLATED BOTH THE BALLOONS AT 350PSI, AFTER 2-3 MINUTES HE DEFLATED THE BALLOON AND STARTED TO FILL UP THE CEMENT, DURING WHICH THE CONTROLATERAL BALLOON RUPTURED. THE PRODUCT CAME IN CONTACT OF THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674228 KYPHON® EXPRESS¿ INFLATABLE BONE TAMP ARTHROSCOPE HRX MDT KYPHON NEUCHATEL MFG NA 0008050374

    Patients

    Seq Age Sex Outcome Treatment
    1