BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON EXPRESS INFLATABLE BONE TAMP

    MDR report key: 6957241 · Received October 17, 2017

    Report

    Report Number
    2953769-2017-00109
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    September 15, 2017
    Report Date
    April 13, 2018
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    HRX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# KE152, 510K# K123771 AND UPN (B)(4) IS APPROVED FOR SALE IN THE MARKET. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE IBT HAS A SMALL CUT IN THE BALLOON PERPENDICULAR TO THE SHAFT OF THE IBT. THESE TYPES OF CUTS ARE CONSISTENT WITH THE BALLOON COMING IN CONTACT WITH BONE SPURS. ONLY ONE IBT WAS RETURNED OF THE TWO BALLOONS REPORTED AND IT IS UNKNOWN WHICH BALLOON WAS RETURNED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: VERTEBRAL COMPRESSION FRACTURE. IT WAS REPORTED THAT INTRA-OP, BALLOON BURST ON INFLATION. THE BALLOON WAS RUPTURED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733490 KYPHON EXPRESS INFLATABLE BONE TAMP ARTHROSCOPE HRX MDT KYPHON NEUCHATEL MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1