BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON KIS

    MDR report key: 23677982 · Received December 1, 2025

    Report

    Report Number
    9617601-2025-03073
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Date of Event
    November 7, 2025
    Report Date
    December 1, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    HXG
    UDI-DI
    00763000312039
    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

    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. 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 BALLOON KYPHOPL ASTY DUE TO T10 COMPRESSION FRACTURE (PRIMARY OSTEOPOROSIS). IT WAS REPORTED THAT THE IBTRUPTURED DURING EXPANSION (APPROXIMATELY 1.5 CC AT 300 PSI); THERE WAS NO RETAINED BALLOON FRAGMENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER CLEANING AND CEMENT FILL WITH FINAL INSTRUMENTATION, WITHOUT DELAY OR HOSPITALIZATION. THE PATIENT EXPERIENCED NO SYMPTOMS OR COMPLICATIONS AND RECOVERED WITH NO HEALTH DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1948989 KYPHON KIS TAMP HXG MEDTRONIC MEXICO S. DE R.L. DE CV KE152 UNKNOWN 00763000312039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown