BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON EXPRESS¿ II INFLATABLE BONE TAMP

    MDR report key: 23257688 · Received October 9, 2025

    Report

    Report Number
    9617601-2025-01914
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    September 18, 2025
    Report Date
    November 11, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    HRX
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RADIOGRAPHIC IMAGE REVIEW STATES, LATERAL VIEW OF BALLOON KYPHOPLASTY INTRA-OP AT T LEVEL SHOWS 1 BALLOON INFLATED. LATERAL VIEW OF BOTH BALLOONS APPEARS INFLATED. ACCESS NEEDLES AND BALLOONS REMOVED. RADIOPAQUE CONTRAST IS SEEN IN VERTEBRAL BODY. ANTERO-POSTERIOR VIEW OF 1 <(>&<)> 2 SHOWS BALLOONS EXPLODED. 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

    H6: 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. 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. IT WAS REPORTED THAT WHEN THE PHYSICIAN INFLATED TWO BALLOONS, THEY BURST AT 220 PSI WHILE IN CONTACT WITH THE FRACTURE OF THE SUPERIOR VERTEBRAL ENDPLATE. PRIOR TO BURSTING, THE BALLOONS WERE SQUACHED AND UNABLE TO RAISE THE UPPER VERTEBRAL PLATEAU. AND DUE TO THE CHAPE OF THE BALLOONS, IT CAUSED LEAKS AT THE LEVEL OF THE VERTEBRAL WALLS WHICH SUBSEQUENTLY LED TO CEMENT LEAKS. THE PRODUCT WAS DISCARDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1577442 KYPHON EXPRESS¿ II INFLATABLE BONE TAMP ARTHROSCOPE HRX MEDTRONIC MEXICO S. DE R.L. DE CV KEX202EB-INT 231061083

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Unknown