BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVOS¿ BONE CEMENT

    MDR report key: 22768693 · Received August 11, 2025

    Report

    Report Number
    3003120897-2025-00065
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    July 30, 2025
    Report Date
    August 11, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NDN
    UDI-DI
    00643169097766
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: COUNTRY OF ORIGIN IS AUSTRIA G4: SIMILAR DEVICE WITH PRODUCT# CX01A WITH 510(K)# K102397, UDI # (B)(4), IS MARKETED IN UNITED STATES. H6 - THE DEVICE WAS NOT 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. 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 SPINAL THERAPY. IT WAS REPORTED THAT WHEN THE USER ATTEMPTED TO MIX THE BONE CEMENT, THE LIQUID PART OF THE CEMENT WAS ALREADY HARDENED IN THE GLASS AMPOULE. THE PRODUCT WAS NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE THERAPY/ PROCEDURE INVOLVED WAS BALLOON KYPHOPLASTY AND STABILISATION FRACTURE IN THE VERTEBRAL BODY OF THE 12TH THORACIC VERTEBRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2135385 ACTIVOS¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC. C05A FAGJ184 00643169097766

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown