BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON KIS

    MDR report key: 23678247 · Received December 1, 2025

    Report

    Report Number
    9617601-2025-03074
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Date of Event
    November 6, 2025
    Report Date
    January 6, 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 # (B)(4), PRODUCT:KE152, VISUAL INSPECTION DID NOT REVEAL ANY DAMAGE TO THE IBT. FUNCTIONAL INSPECTION CONFIRMED THE IBT WOULD NOT INFLATE TO EXPOSE ANY LEAK S/PUNCTURES IN THE BALLOON DUE TO THE DRIED CONTRAST INSIDE THE IBT SHAFT/BALLOON. 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

    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 L1 PERCUTANEOUS VERTEBROPLASTY THERAPY FOR PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE. IT WAS REPORTED THAT THE BALLOON DID NOT INFLATE DURING IBT USE. WHEN THE BALLOON WAS CHECKED OUTSIDE THE SURGICAL FIELD, IT WAS CONFIRMED TO INFLATE NORMALLY AND THE PRESSURE INCREASED. AT THE TIME OF REMOVAL AFTER IBT USE, BLOOD WAS FOUND TO HAVE ACCUMULATED INSIDE THE BALLOON. THERE WAS LIKELY A PERFORATION. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2745518 KYPHON KIS ARTHROSCOPE HRX MEDTRONIC MEXICO S. DE R.L. DE CV KE152 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown