BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON EXPRESS II INFLATABLE BONE TAMP

    MDR report key: 23276836 · Received October 15, 2025

    Report

    Report Number
    9617601-2025-01949
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 18, 2025
    Report Date
    November 14, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    HRX
    UDI-DI
    00763000026929
    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

    ADDITIONAL INFORMATION: B5. 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 NEW CALEDONIA. G4. PLEASE NOTE THAT THE INVOLVED DEVICE IS NOT MARKETED IN THE UNITED STATES; HOWEVER, THE DEVICE IS DEEMED THE SAME AS THE UNITED STATES MARKETED DEVICE (PRODUCT ID: KEX152EB; UPN: 00763000026912; 510(K) NO: K123771). 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

    ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE EVENT. THE PATIENT WAS HAVING L1 KYPHOPLASTY PROCEDURE. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

    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 SUPERIOR VERTEBRAL ENDPLATE WAS NOT LIFTED AND BOTH BALLOONS BURST AT 400 PSI WHEN IN CONTACT WITH THE FRACTURE OF THE SUPERIOR VERTEBRAL ENDPLATE. DUE TO THIS EVENT, ANOTHER KYPHO PACK WAS REQUIRED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178586 KYPHON EXPRESS II INFLATABLE BONE TAMP ARTHROSCOPE HRX MEDTRONIC MEXICO S. DE R.L. DE CV KEX152EB-INT 231489667 00763000026929

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female