BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SOLERA 5.5/6.0

    MDR report key: 24159068 · Received January 23, 2026

    Report

    Report Number
    3003120897-2026-00122
    Event Type
    Malfunction
    Date Received
    January 23, 2026
    Date of Event
    December 30, 2025
    Report Date
    January 23, 2026
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    HXX
    UDI-DI
    00613994429742
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS # (B)(4): PART # 5480004V, LOT# K23E3091. VISUAL AND OPTICAL EXAMINATION IDENTIFIED IT APPEARS THAT PART OF THE TIP OF THE INSTRUMENT HAS BEEN BROKEN OFF. THE METAL DEFORMATION GIVES INDICATION THAT THE FAILURE WAS THE RESULT OF 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 USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DRIVERS USED FOR SPINAL THERAPY. IT WAS RE PORTED THAT DURING ROUTINE INSTRUMENT INSPECTION, THE INSTRUMENTS WERE AS WORN BEYOND USABLE SPECIFICATIONS. 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
    223239 CD HORIZON SOLERA 5.5/6.0 SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC. 5480004V K23E3091 00613994429742

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown