BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SOLERA® SPINAL SYSTEM

    MDR report key: 23922096 · Received December 30, 2025

    Report

    Report Number
    3014725904-2025-00153
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    October 17, 2025
    Report Date
    December 30, 2025
    Manufacturer
    MEDTRONIC MEDICAL COSTA RICA S.R.L.
    Product Code
    KWP
    UDI-DI
    00643169584518
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER DETAILS ARE UNKNOWN. G2: COUNTRY OF ORIGIN IS JAPAN. G4 510(K)#: THIS DEVICE WITH PRODUCT ID: 1664017, UDI: (B)(4) IS NOT MARKETED IN UNITED STATES BUT HOWEVER, A SIMILAR DEVICE WITH PRODUCT ID: 6540530, UDI: (B)(4), 510(K)# K170679 IS MARKETED IN UNITED STATES. H3: PRODUCT ANALYSIS #708647930: PART # 1664017, LOT# 0086966C VISUAL AND MACROSCOPIC INSPECTION CONFIRMED THE THREADS OF THE BREAK OFF SCREW HAVE BEEN DAMAGED. THE THREAD CREST AND FLANK DAMAGE APPEAR TO HAVE INITIATED AT THE START OF THE THREAD AND IS CONSISTENT AROUND THE DAMAGED PORTION OF THE THREAD. FUNCTIONAL EVALUATION WITH A SAMPLE MAS FOUND THE SET SCREW UNABLE TO BE FULLY ENGAGED IN THE MAS HEAD. THIS IS CONSISTENT WITH MISALIGNMENT OF THE MAS AND SET SCREW THREADS DURING CONSTRUCT ASSEMBLY. 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 SET SCREW REPLA CEMENT, POSTERIOR LUMBAR INTERBODY FUSION (PLIF) THERAPY FOR L5/S STENOSIS. IT WAS REPORTED THAT WHEN THE SET SCREW WAS PROVISIONALLY TIGHTENED TO THE END OF THE THREAD (JUST BEFORE TORQUE-OUT), THE SCREW HEAD DID NOT BECOME FIXED TO THE ROD AND REMAINED LOOSE AND WOBBLY. EVEN AFTER THE ROD WAS REINSERTED SEVERAL TIMES AND AN ATTEMPT WAS MADE TO PROVISIONALLY TIGHTEN THE SET SCREW AGAIN, THE SAME RESULT WAS OBSERVED. 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
    2272880 CD HORIZON® SOLERA® SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC MEDICAL COSTA RICA S.R.L. 1664017 0086966C 00643169584518

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown