BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON XPANDER

    MDR report key: 11555429 · Received March 23, 2021

    Report

    Report Number
    9612164-2021-01115
    Event Type
    Malfunction
    Date Received
    March 23, 2021
    Date of Event
    February 11, 2021
    Report Date
    March 23, 2021
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    HRX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. PRODUCT IS NOT MARKETED IN US. 510(K) FOR SIMILAR DEVICE MARKETED IN US WITH CATALOGUE #KPX203RB IS K101864. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF VERTEBRAL COMPRESSION FRACTURE (VCF) FOR YOUNG PEOPLE (TRAUMA) INVOLVED IN KYPHOPLASTY PROCEDURE. LEVEL TREATED- LUMBAR LEVEL. IT WAS REPORTED THAT AT INTRA-OP, DURING THE INFLATION OF THE BALLOON (AT 300 PSI) THERE WAS A DISRUPTION/RUPTURE OF A BALLOON. NO RUPTURED FRAGMENT LET IN THE PATIENT BODY. THE SURGEON SAID THAT PATIENT COULDN'T HAVE A GOOD REDUCTION OF THE FRACTURE. THERE WAS NO PROBLEM WITH THE PATIENT. THERE WAS A DELAY IN OVERALL PROCEDURE TIME OF 15 MINUTES. NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. PROCEDURE WAS COMPLETED WITH NEW PRODUCT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS THE RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454427 KYPHON XPANDER ARTHROSCOPE HRX MEDTRONIC MEXICO KPX203PB-C 221316656

    Patients

    Seq Age Sex Outcome Treatment
    1