BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON® EXPRESS¿ INFLATABLE BONE TAMP

    MDR report key: 6434973 · Received March 27, 2017

    Report

    Report Number
    2953769-2017-00026
    Event Type
    Malfunction
    Date Received
    March 27, 2017
    Date of Event
    February 28, 2017
    Report Date
    May 18, 2017
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    HRX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT MARKETED IN US BUT A SIMILAR PRODUCT WITH CATALOG # KE202, 510K# K123771 AND UDI # (B)(4) IS AVAILABLE FOR SALE IN U.S. THE PRODUCT IS NOT RETURNED TO MANUFACTURER FOR EVALUATION; THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT. PRODUCT IMAGE REVIEW: SUBMITTED IMAGES APPEAR TO DISPLAY RADIALLY CUT IBT BALLOON.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: DURING FUNCTIONAL ANALYSIS, IT WAS NOT MORE POSSIBLE TO INFLATE THE BALLOON. PRESENCE OF BLOOD IN AND ON THE IBT. DURING VISUAL ANALYSIS, IT APPEARS THAT THE SHAFT OF THE IBT IS STRONGLY DEFORMED AND THE BALLOON IS RUPTURED IN TWO PARTS. CONCLUSION: BASED ON THE INFORMATION PROVIDED, FUNCTIONAL AND VISUAL ANALYSIS, THE MOST PROBABLE ROOT CAUSE OF THE RUPTURE OF THE BALLOON IS ATTRIBUTED TO THE CONTACT WITH BONE SPLINTERS DURING SURGERY. AFTER THAT, THE BALLOON WAS PROBABLY STUCK IN THE VERTEBRAL BODY AND THE COMPLETE RUPTURE AND THE DEFORMATION OF THE SHAFT HAPPENED WHEN THE SURGEON HAS TAKEN THE BALLOON OUT OF THE VERTEBRAL BODY. 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WITH OSTEOPOROSIS UNDERWENT BALLOON KYPHOPLASTY AT L2 LEVEL. INTRA-OP, BALLOON EXPLODED WHILE INFLATING IN A COMPRESSED VERTEBRA ON A MAXIMUM PRESSURE 250 PSI AND AT A MAXIMUM INFLATION VOLUME OF 3.5 CC. THE PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA. NO FRAGMENTS OF RUPTURED BALLOON WERE LEFT INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218739 KYPHON® EXPRESS¿ INFLATABLE BONE TAMP ARTHROSCOPE HRX MDT KYPHON NEUCHATEL MFG NA 0008081999

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR