BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM

    MDR report key: 23921230 · Received December 30, 2025

    Report

    Report Number
    3003120897-2025-00828
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    October 14, 2025
    Report Date
    December 30, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS: PRODUCT: 6550017, LOT: K24F1188 VISUAL AND MICROSCOPIC EXAMINATION CONFIRMED THAT THE TAB WAS BENT. THIS TYPE OF DAMAGE 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 A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A L2-L5 OLIF+PPS PROCEDURE IN A PATIENT DIAGNOSED WITH LUMBAR SPINAL STENOSIS. IT WAS REPORTED THAT ON THE DAY AFTER SURGERY, THE DISTRIBUTOR NOTIFIED THAT DEFORMATION OF THE TAB WAS OBSERVED WHEN THE INSTRUMENT WAS RETRIEVED FOR RETURN AND THE MOVEMENT OF THE JOINT IN THE ANTERIOR RACK MOUNT WAS LESS SMOOTH (STIFFER) THAN USUAL. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1769587 CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED M HWE MEDTRONIC SOFAMOR DANEK USA, INC. 6550017 K24F1188 00643169961623

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown