BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM

    MDR report key: 25199585 · Received May 18, 2026

    Report

    Report Number
    3003120897-2026-00905
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    February 25, 2026
    Report Date
    May 18, 2026
    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: PRODUCT ID# 6550017 LOT# K24L1142 VISUAL AND OPTICAL EXAMINATION REVEALED THE TIP OF THE INSTRUMENT IS BENT FROM WHAT APPEARS TO BE OVERLOAD. THIS 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 MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE WAS DAMAGED.  DEFORMATION OF THE TAB EXTENDER CAP CONNECTION REGION OF THE TAB EXTENDER WAS CONFIRMED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292345 CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED M HWE MEDTRONIC SOFAMOR DANEK USA, INC. 6550017 K24L1142 00643169961623

    Patients

    Seq Age Sex Outcome Treatment
    1