BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM

    MDR report key: 23669467 · Received November 28, 2025

    Report

    Report Number
    3003120897-2025-00636
    Event Type
    Malfunction
    Date Received
    November 28, 2025
    Date of Event
    September 3, 2025
    Report Date
    November 28, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NKB
    UDI-DI
    00643169754584
    PMA / PMN Number
    K170679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PART # 6550017 ; LOT # K24L1335 VISUAL AND OPTICAL INSPECTION CONFIRMED THE END OF THE TAB EXTENDER THAT INTERFACES WITH THE BREAK OFF SCREW HAS BEEN BENT. THE DAMAGE TO THE EXTENDER IS CONSISTENT WITH BEND STRESS 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. 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, DEFORMATION OF THE TAB WAS IDENTIFIED WHILE CLEANING UP THE EQUIPMENT THE DAY AFTER THE OPERATION. PROCEDURE PERFORMED WAS POSTERIOR LUMBAR INTERBODY FUSION AND THE LEVELS TREATED WERE L4/5. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLIC ATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2149718 CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MEDTRONIC SOFAMOR DANEK USA, INC. 6550017 K24L1335 00643169754584

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown