BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON XPEDE BONE CEMENT

    MDR report key: 22491685 · Received July 14, 2025

    Report

    Report Number
    6000033-2025-00081
    Event Type
    Malfunction
    Date Received
    July 14, 2025
    Date of Event
    June 18, 2025
    Report Date
    July 14, 2025
    Manufacturer
    CARDIAC SURGERY MFG KERKRADE
    Product Code
    NDN
    UDI-DI
    00763000269807
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: THE COUNTRY OF THE EVENT IS GERMANY. G4. PLEASE NOTE THAT THIS DEVICE (CX01B-C) IS NOT MARKETED IN THE UNITED STATES; HOWEVER, IT IS SAME TO THE UNITED STATES MARKETED DEVICE WITH CATALOG# CX01B, 510K# K102397 AND UDI# ((B)(4). H3: 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 DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE CEMENT HARDENED TOO FAST, WAS CLUMPY, AND COULD NOT BE MIXED. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1677664 KYPHON XPEDE BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN CARDIAC SURGERY MFG KERKRADE CX01B-C 231160532 00763000269807

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown