BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON KIS

    MDR report key: 21879737 · Received April 22, 2025

    Report

    Report Number
    9612164-2025-01985
    Event Type
    Malfunction
    Date Received
    April 22, 2025
    Date of Event
    April 1, 2025
    Report Date
    October 6, 2025
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    HXG
    UDI-DI
    00763000311902
    PMA / PMN Number
    K041454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS:PART # K08A : LOT # 230283089 VISUAL AND OPTICAL INSPECTION CONFIRMED THE IBT IS JAMMED IN THE INTRODUCER. THE IBT APPEARS TO HAVE BEEN DAMAGED IN THE VERTEBRAL BODY CAUSING THE BALLOON TO TEAR AND DEFORM WHILE BEING PULLED BACK THROUGH THE INTRODUCER. 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 BALLOON KYP HOPLASTY DUE TO COMPRESSION FRACTURE. IT WAS REPORTED THAT THE BALLOON GOT LODGED INSIDE THE TROCAR AND WAS UNABLE TO BE PULLED OUT, THE TROCAR STYLET WAS REMOVED, THE INTELIFLATOR WAS REMOVED AND THE LOCKING SYRINGE WAS UTILIZED TO REMOVE ANY EXCESS FLUID, THE WHOLE TROCAR HAD TO BE REMOVED AND A NEW ONE INSERTED. BALLOON RUPTURED DURING DEFLATION. 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
    1239431 KYPHON KIS ARTHROSCOPE HXG MEDTRONIC MEXICO K08A 230283089 00763000311902

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown