BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 23742433 · Received December 8, 2025

    Report

    Report Number
    3003120897-2025-00696
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    November 13, 2025
    Report Date
    December 8, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    HXX
    UDI-DI
    00643169043640
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PRODUCT NO:5584111, LOT NO: K23D1225, VISUAL INSPECTION CONFIRMED THE ENTIRE TORX TIP OF INSTRUMENT HAS BEEN SHEARED OFF. OPTICAL EXAMINATION OF THE FRACTURE SURFACE REVEALED A FAIRLY FLAT FRACTURE SURFACE AND CIRCULAR MATERIAL FLOW. THE DAMAGE TO THE DRIVER IS CONSISTENT OVERLOAD. 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 USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING FEW DEVICES USED FOR SPINAL THERAPY. IT WAS REPORTED THAT ALL THE INSTRUMENTS ARE BROKEN OR WORN FROM USE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE STATING THAT TWO DRIVERS HAS BROKEN OFF TIPS AND ONE ROD REDUCER WAS MISSING A SCREW AND CAME UNHINGED. THE REMAINING ITEMS WERE WORN SUCH THAT THEY NO LONGER PERFORMED CORRECTLY. ALL INVOLVED PHYSICIANS AND STAFF HAVE BEEN NOTIFIED OF OUR ACTIONS TO REPLACE THESE ITEMS. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157325 CD HORIZON® SPINAL SYSTEM SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC. 5584111 K23D1225 00643169043640

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown