BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SOLERA¿ FENESTRATED SCREW SPINAL SYSTEM

    MDR report key: 23754657 · Received December 9, 2025

    Report

    Report Number
    2647346-2025-00239
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Date of Event
    November 14, 2025
    Report Date
    February 12, 2026
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    MNI
    UDI-DI
    00643169374423
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: THIS PRODUCT IS NOT MARKETED IN US BUT A SIMILAR DEVICE WITH PRODUCT NUMBER 55840027540T WITH 510(K)# K152604 AND UDI (B)(4) IS MARKETED IN US. 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 OF PRODUCT: (B)(4), LOT: H6051622 VISUAL AND MICROSCOPIC EXAMINATION CONFIRMED THAT THE LIP ON THE TULIP HEAD OF THE SCREW WAS BROKEN. THIS IS CONSISTENT WITH MISALIGNMENT. 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 SPINAL THERAPY. IT WAS REPORTED THAT UPON PLACING A ROD AND SET SCREW THE PHYSICIAN ENCOUNTERED A DIFFICULTY INSERTING A SET SCREW IN THE SCREW TULIP AS SCREW TULIP LIP WAS DAMAGED. THE SCREW WAS REMOVED BY THE PHYSICIAN USING A K-WIRE AND REPLACED WITH ANOTHER FNS SCREW FOR COMPLETION OF SURGERY. 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
    416339 CD HORIZON® SOLERA¿ FENESTRATED SCREW SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION MNI MDT PUERTO RICO OPERATIONS CO, MED REL 55840027540 H6051922 00643169374423

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male