BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON EXPRESS¿ II INFLATABLE BONE TAMP

    MDR report key: 23035767 · Received September 12, 2025

    Report

    Report Number
    9617601-2025-01413
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    August 27, 2025
    Report Date
    November 12, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    HRX
    UDI-DI
    00763000026950
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS #(B)(4), PRODUCT:KEX202EB-INT, LOTNO:231382336 VISUAL INSPECTION CONFIRMED THE SHAFT OF THE IBT AND THE BALLOON HAS BEEN DAMAGED. THE INNER WIRE IS ALSO MISSING. THE DAMAGE OBSERVED ON THE IBT SHAFT SUGGESTS IT WAS CAUSED BY OVERLOAD, WHILE THE DAMAGE TO THE BALLOON INDICATES IT WAS INFLATED WITHIN THE VERTEBRAL BODY AND SUBSEQUENTLY PUNCTURED BY A BONE SPUR. 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: COUNTRY OF ORIGIN IS FRANCE G4: THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# KEX152EB, 510K # K123771 AND UDI (B)(4) IS APPROVED FOR SALE IN US. 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 HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR TUMOR IN L4 AND NEED TO CONSOLIDATE THE CENTER OF VERTEBRA. IT WAS REPORTED THAT THERE WAS VERY DIFFICULT TO PUSH WITH THE BALLOON, EVEN WHEN A DRILL WAS USED BY THE RADIOLOGIST. THE INJECTOR INDICATED A RED LIGHT WITH PSI OVER 750, AND THE CATHETER BROKE. ADDITIONALLY, AFTER 3ML, THE BALLOON BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW PRODUCT. NO PATIENT SYMPTOMS OR COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE CATHETER WITH THE BALLOON ON THE DISTAL PART BROKE. THE INJECTION OF CEMENT WAS NOT TOTALLY EFFICIENT, BUT THEY CAN INJECTED CEMENT AT THE END OF THE PROCEDURE. DELAY IN THE PROCEDURE WAS LESS THAN 60 MINUTES. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE THERAPY/PROCEDURE INVOLVED WAS BALLOON KYPHOPLASTY IN LEVEL L4 FOR CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2202770 KYPHON EXPRESS¿ II INFLATABLE BONE TAMP ARTHROSCOPE HRX MEDTRONIC MEXICO S. DE R.L. DE CV KEX202EB-INT 231382336 00763000026950

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown