BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 21442949 · Received February 24, 2025

    Report

    Report Number
    1030489-2025-00933
    Event Type
    Malfunction
    Date Received
    February 24, 2025
    Date of Event
    December 6, 2024
    Report Date
    February 24, 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
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS: PART # 9010000849, LOT # K23B1056 VISUAL AND FUNCTIONAL INSPECTION REVEALED THE INNER SHAFT DOES NOT MOVE WHEN THE LOCKING LEVER IS MOVED. THE C CLIP THAT CONNECTS THE ADJUSTING MECHANISM TO THE INNER SHAFT APPEARS TO HAVE BEEN OVERLOADED AND BROKEN. IT IS POSSIBLE TO OVERLOAD THE CLIP WHEN MAKING TENSION ADJUSTMENTS WHILE THE ROD IS IN PLACE. IT APPEARS THE C CLIP BROKE FROM EXCESSIVE FORCE. 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 A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT. IT WAS REPORTED THAT THE ROD HOLDER DOESN¿T LOOSEN UP ANYMORE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404726 CD HORIZON® SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC 9010000849 K23B1056 00643169537736

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown