BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON XPANDER¿ II INFLATABLE BONE TAMP

    MDR report key: 22892225 · Received August 26, 2025

    Report

    Report Number
    9617601-2025-01161
    Event Type
    Malfunction
    Date Received
    August 26, 2025
    Date of Event
    August 7, 2025
    Report Date
    August 26, 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
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: LOT# IS UNKNOWN G2: COUNTRY OF ORIGIN IS GERMANY G5: THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # KX203, 510K # K101864 AND UDI # (B)(4) WAS APPROVED IN THE UNITED STATES. 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 THE BALLOON BURST AT 90 PSI. THERE WAS NO PATIENT INVOLVED. THERE WERE NO FURTHER COMPLICATIONS REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE PROCEDURE INVOLVED WAS BALLOON KYPHOPLASTY FOR OSTEOPOROTIC FRACTURE. LEVELS INVOLVED WAS L1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2666212 KYPHON XPANDER¿ II INFLATABLE BONE TAMP ARTHROSCOPE HRX MEDTRONIC MEXICO S. DE R.L. DE CV KX203-C UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown