BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON EXPRESS II INFLATABLE BONE TAMP

    MDR report key: 23551613 · Received November 14, 2025

    Report

    Report Number
    9617601-2025-02732
    Event Type
    Malfunction
    Date Received
    November 14, 2025
    Date of Event
    October 16, 2025
    Report Date
    January 14, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    HRX
    UDI-DI
    00763000026899
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PART# KEX102EB-INT, LOT# 228866470 VISUAL AND OPTICAL INSPECTION CONFIRMED DRIED BIO MATTER IN THE SHAFT OF THE INTRODUCERS. FUNCTIONAL INSPECTION AFTER THE INTRODUCERS WERE CLEANED CONFIRMED THE IBT WAS ABLE TO PASS THROUGH THE INTRODUCER WITHOUT ANY ISSUE. THE INSTRUMENT FUNCTIONS AS INTENDED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    G2: THE COUNTRY OF THE EVENT IS CANADA. G4. PLEASE NOTE THAT THIS DEVICE (KEX102EB-INT) IS NOT MARKETED IN THE UNITED STATES; HOWEVER, IT IS SAME AS THE UNITED STATES MARKETED DEVICE WITH CATALOG# KEX102EB, 510K# K123771 AND UPN 00763000026882. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A USER REPORT REGARDING A PATIENT HAVING KYPHOPLASTY. IT WAS REPORTED THAT T HE PHYSICIAN HAD DIFFICULTY PASSING THE BALLOONS THROUGH THE INTRODUCERS IN ORDER TO DO THE PLASTY PORTION OF THE PROCEDURE. UNABLE TO FULLY PASS THROUGH ON BOTH INTRODUCERS. ADDITIONAL FRACTURE KIT OPENED, AND NEW BALLOONS PASSED SUCCESSFULLY THROUGH THE TROCARS THAT REMAINED IN SITU FROM THE PREVIOUS KIT. THERE WAS UNEXPECTED DELAY IN PROCEDURE TIME. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146831 KYPHON EXPRESS II INFLATABLE BONE TAMP ARTHROSCOPE HRX MEDTRONIC MEXICO S. DE R.L. DE CV KEX102EB-INT 228866470 00763000026899

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown