BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM

    MDR report key: 24921056 · Received April 19, 2026

    Report

    Report Number
    3003120897-2026-00723
    Event Type
    Malfunction
    Date Received
    April 19, 2026
    Date of Event
    March 25, 2026
    Report Date
    May 4, 2026
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    HWE
    UDI-DI
    00643169754584
    PMA / PMN Number
    K170679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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

    H3:PRODUCT ANALYSIS :PART # 6550017 LOT # K23G1110 VISUAL AND OPTICAL INSPECTION CONFIRMED THE EXTENDER TABS HAVE BEEN BENT DUE TO 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 RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A MULTIPLE DEVICES USED FOR SPINAL THERAPY. IT WAS REPORTED THAT A SCREW WAS ATTEMPTED TO BE IMPLANTED, BUT THE HANDLE BROKE INTO TWO PIECES, THE TIPS OF THE TAB EXTENSION HAVE BENT AND WILL NOT ATTACH TO THE RING CONNECTION PIECE AND THE DRIVER WAS STRIPPED AND WILL NOT PROPERLY ENGAGE WITH A SCREW. A REMOVAL BIT WAS PLACED INTO EXTENSION ATTACHMENT THEN A SCREW WAS ATTEMPTED TO BE EXPLANTED, AND THE DRILL BIT SUBSEQUENTLY CAME OUT OF THE EXTENSION PIECE. WHILE ANOTHER SCREW WAS ATTEMPTED TO BE IMPLANTED, ANOTHER HANDLE STOPPED RATCHETING. THERE WERE NO PATIENT SYMPTOMS INVOLVED IN THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7713 CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED M HWE MEDTRONIC SOFAMOR DANEK USA, INC. 6550017 K23G1110 00643169754584

    Patients

    Seq Age Sex Outcome Treatment
    1