BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 21705037 · Received March 27, 2025

    Report

    Report Number
    1030489-2025-01552
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    December 20, 2024
    Report Date
    March 27, 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
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS #(B)(4), PRODUCT #9010000849, LOT #K22K1121 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 THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED IN PERCUTANEOUS POSTERIOR SCREW FIXATION THERAPY FOR BACK PAIN, SCIATICA. LEVELS IMPLANTED WERE L5-S1. IT WAS REPORTED THAT UPON IMPLANTING THE PERCUTANEOUS ROD ON THE PATIENT¿S LEFT SIDE, THERE WAS A SNAPPING NOISE. UPON HEARING THE NOISE, THE SURGEON PULLED THE INSERTER OUT OF THE WOUND AND REALIZED THE ROD HAD RELEASED FROM THE INSERTER. ROD WAS THEN FISHED OUT WITH A KOCHER. ATTEMPTED TO RE-ENGAGE ROD WITH INSERTER BUT THE INSERTER WAS NOT WORKING PROPERLY AND WOULD NOT ENGAGE ROD ANY LONGER. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2416088 CD HORIZON® SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC 9010000849 K22K1121 00643169537736

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male