BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON XPANDER II INFLATABLE BONE TAMP

    MDR report key: 6953931 · Received October 17, 2017

    Report

    Report Number
    2953769-2017-00107
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    September 26, 2017
    Report Date
    April 16, 2018
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    HRX
    UDI-DI
    00643169093676
    PMA / PMN Number
    K101864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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: THERE IS A CUT IN THE BALLOON RUNNING PARALLEL WITH THE IBT SHAFT. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE BALLOON COMING IN CONTACT WITH BONE DURING INFLATION. 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 FRACTURE AT "BWK 11" UNDERWENT BALLOON KYPHOPLASTY.INTRA-OP, THE BALLOON BURST WHILE INFLATING. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736499 KYPHON XPANDER II INFLATABLE BONE TAMP ARTHROSCOPE HRX MDT KYPHON NEUCHATEL MFG NA 0008726295 00643169093676

    Patients

    Seq Age Sex Outcome Treatment
    1