BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM

    MDR report key: 23766559 · Received December 10, 2025

    Report

    Report Number
    3003120897-2025-00714
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    September 3, 2025
    Report Date
    December 10, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    HWE
    UDI-DI
    00643169961623
    PMA / PMN Number
    K170679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PART # 6550017, LOT # K25A1044 - VISUAL AND OPTICAL INSPECTION CONFIRMED THE BREAK OFF TAB OF THE SCREW IS JAMMED IN THE BENT EXTENDER. THE DAMAGE TO THE EXTENDER APPEARS TO BE FROM 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 L1/2/5/S FIXED IN THE PERCUTANEOUS PEDICLE SCREW FOR PYOGENIC SPONDYLITIS. IT WAS REPORTED THAT WHEN TRIED TO FOLD THE TAB IN THE SURGICAL FIELD, THE TAB BROKE IN THE MIDDLE, NOT THE BASE OF THE SCREW HEAD. PRESSURE WAS APPLIED WITH THE TAB-BREAKING INSTRUMENT WITHOUT FULLY INSERTING IT DOWN TO THE BASE OF THE SCREW. 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
    2871183 CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED M HWE MEDTRONIC SOFAMOR DANEK USA, INC. 6550017 K25A1044 00643169961623

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown