BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON KIS

    MDR report key: 23789764 · Received December 12, 2025

    Report

    Report Number
    9617601-2025-03432
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    November 21, 2025
    Report Date
    February 9, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    HRX
    PMA / PMN Number
    K123771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PRODUCT:KE152, LOTNO:UNKNOWN VISUAL AND OPTICAL INSPECTION REVEALED THE TIP OF THE BALLOON HAS BEEN DAMAGED. THE UPPER PORTION OF THE BALLOON HAS BEEN PUNCTURED. THIS DAMAGE IS CONSISTENT WITH THE BALLOON COMING IN CONTACT WITH BONE SPURS WHEN THE BALLOON IS INFLATED IN THE VERTEBRAL BODY. 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

    D4: LOT NUMBER IS UNKNOWN E1: INITIAL REPORTER IS UNKNOWN. 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 L2 VERTEBROPLA STY THERAPY FOR PRIMARY OSTEOPOROSIS AND A COMPRESSION FRACTURE. IT WAS REPORTED THAT DURING THE PROCEDURE, AN INFLATION BALLOON RUPTURED ON THE RIGHT-SIDE WHILE BEING EXPANDED AT APPROXIMATELY 175 PSI WITH A VOLUME OF 1.5CC. THE RUPTURE OCCURRED DURING BALLOON EX PANSION. 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
    2713398 KYPHON KIS ARTHROSCOPE HRX MEDTRONIC MEXICO S. DE R.L. DE CV KE152 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown