BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON EXPRESS II INFLATABLE BONE TAMP

    MDR report key: 7333875 · Received March 13, 2018

    Report

    Report Number
    2953769-2018-00013
    Event Type
    Malfunction
    Date Received
    March 13, 2018
    Date of Event
    February 13, 2018
    Report Date
    October 3, 2018
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HRX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE IBT RETURNED HAD RADIAL RUPTURE OF THE BALLOON ON THE DISTAL PEAK. THIS CAN BE CAUSED BY THE BALLOON COMING IN CONTACT WITH BONE SPLINTERS IN THE VERTEBRAL BODY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# KE152, 510K# K123771 AND UDI (B)(4) IS APPROVED FOR SALE IN US. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT.

    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 THE PATIENT PRE-OPERATIVELY DIAGNOSED WITH BONE METS AT L5 DUE TO PROSTATE CANCER UNDERWENT KYPHOPLASTY. INTRA-OP, BALLOON BURST DURING INFLATION AT LOW PSI AT LEVEL L5. A NEW KIT WAS OPENED. SURGEON USED A CURETTE AND BONE TAMP TO ENSURE BONE SHARDS WEREN'T AN ISSUE DURING INFLATION. THE EVENT MIGHT BE DUE TO SCLEROTIC BONE FROM PROSTATE OSTEOBLASTIC LESION BUT NOT SURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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
    177566 KYPHON EXPRESS II INFLATABLE BONE TAMP ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1