BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 22269101 · Received June 18, 2025

    Report

    Report Number
    1030489-2025-02256
    Event Type
    Malfunction
    Date Received
    June 18, 2025
    Date of Event
    April 21, 2025
    Report Date
    June 18, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    KWP
    UDI-DI
    00643169537736
    PMA / PMN Number
    K132639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS #(B)(4) PRODUCT ID #9010000849 LOT #K23D1101 VISUAL AND FUNCTIONAL INSPECTION THE INNER SHAFT DOES NOT MOVE WHEN THE LOCKING LEVER IS MOVED. THE "C" CLIP THAT CONNECTS THE ADJUSTING MECHANISM TO THE SHAFT APPEARS TO HAVE COME OUT. THE INNER SHAFT HAS BECOME UNTHREADED AND WILL NO LONGER THREAD BACK IN. IT IS POSSIBLE TO OVERLOAD THE CLIP IF MAKING TENSION ADJUSTMENTS WHILE THE ROD IS IN PLACE. IT APPEARS THAT THE CLIP MAY HAVE BEEN OVERLOADED. 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 USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT WHILE CHECKING IF THE INSTRUMENT WAS WORKING IN STERILE PROCESSING DEPARTMENT (SPD), THE ROD GRIPPER DID NOT CLOSE DOWN ON THE ROD. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430004 CD HORIZON® SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC 9010000849 K23D1101 00643169537736

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown