BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON XPANDER II INFLATABLE BONE TAMP

    MDR report key: 7319731 · Received March 7, 2018

    Report

    Report Number
    1030489-2018-00318
    Event Type
    Malfunction
    Date Received
    March 7, 2018
    Date of Event
    February 8, 2018
    Report Date
    June 29, 2018
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    HRX
    PMA / PMN Number
    K101864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THE PRODUCT IS NOT RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: VISUAL AND MICROSCOPIC EXAMINATION CONFIRMED THAT THE BALLOON HAS CUT ON THE DISTAL PEAK, THIS TYPE OF DAMAGE IS CONSISTENT WITH CONTACT TO BONE SPLINTERS WHILE THE BALLOON IS INFLATED IN THE VERTEBRAL BODY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS PRESENTED WITH VERTEBRAL FRACTURE AT TH-12. INTRA-OP, AT A PRESSURE OF 285 PSI THE IBT BALLOON WAS BURST DURING INFLATION. THE DEVICE CAME IN CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164265 KYPHON XPANDER II INFLATABLE BONE TAMP ARTHROSCOPE HRX MDT KYPHON NEUCHATEL MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1