BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM

    MDR report key: 24258315 · Received February 4, 2026

    Report

    Report Number
    3003120897-2026-00183
    Event Type
    Malfunction
    Date Received
    February 4, 2026
    Date of Event
    January 12, 2026
    Report Date
    March 11, 2026
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    HXX
    UDI-DI
    00643169754515
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS OF PART # 6550004 ; LOT # K22L1255 VISUAL EXAMINATION CONFIRMED THE INSTRUMENT TIP HAS BROKEN. OPTICAL EXAMINATION OF THE FRACTURE SURFACE REVEALED A FAIRLY FLAT FRACTURE SURFACE WITH CIRCULAR MATERIAL FLOW. THE DAMAGE TO THE DRIVER IS CONSISTENT WITH 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 HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, DRIVER TIP BROKE OFF WHEN TRYING TO REMOVE A SET SCREW. BROKEN PART OF THE TIP WAS REMOVED AND DISCARDED. PROCEDURE PERFORMED WAS LUMBAR FUSION/FIXATION. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321095 CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC. 6550004 K22L1255 00643169754515

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female