BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON XPANDER II INFLATABLE BONE TAMP

    MDR report key: 7300382 · Received February 27, 2018

    Report

    Report Number
    1030489-2018-00283
    Event Type
    Malfunction
    Date Received
    February 27, 2018
    Date of Event
    January 30, 2018
    Report Date
    May 17, 2018
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    HRX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: VISUAL AND FUNCTIONAL EVALUATION REVEALED THAT IBT HAD RADIAL RUPTURES NEAR THE PROXIMAL PEEK. ALSO, THE IBTS HAD EXTRA DAMAGE DONE, FROM WHAT APPEARS TO BE PULLING THE BALLOON BACK THROUGH THE CANNULA. THIS TYPE OF RUPTURE IS CONSISTENT WITH CONTACT WITH BONE SPLINTERS WHILE THE BALLOON IS INFLATED 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 US, HOWEVER A LIKE DEVICE WITH PART# KX153, 510K# K101864, AND UPN (B)(4) IS APPROVED FOR MARKET IN THE US. 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 PRE-OPERATIVELY DIAGNOSED WITH VERTEBRAL FRACTURE AT T-7 UNDERWENT A SURGERY. INTRA-OP, BALLOON RUPTURED AT HIGH PRESSURE DURING THE FIRST INSERTION ATTEMPT INTO THE VERTEBRAL BODY. AT THE MOMENT OF CATCHING WITH THE BALLOON SUDDEN PRESSURE LOSS WAS OBSERVED. PRESSURE AND VOLUME REPORTED PRIOR TO RUPTURE WERE 340 PSI-385 PSI AND 1.5 ML RESPECTIVELY. THE PATIENT WAS NOT ALLERGIC TO THE CONTRAST MEDIA. PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142034 KYPHON XPANDER II INFLATABLE BONE TAMP ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR