BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SOLERA® SPINAL SYSTEM

    MDR report key: 22174395 · Received June 10, 2025

    Report

    Report Number
    3014725904-2025-00113
    Event Type
    Malfunction
    Date Received
    June 10, 2025
    Date of Event
    May 13, 2025
    Report Date
    August 14, 2025
    Manufacturer
    MEDTRONIC MEDICAL COSTA RICA S.R.L.
    Product Code
    KWP
    UDI-DI
    00643169545571
    PMA / PMN Number
    SEEH11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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

    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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PART# 1664017 LOT# 1040999W 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 MANUFACTURER REPRESENTATIVE REGARDING PRODUCTS USED IN SPINAL THERAPY FOR L5/S STENOSIS. LEVELS IMPLANTED WAS L5/S. IT WAS REPORTED THAT THE SCREW WAS INITIALLY THREADED, BUT THE HEAD FELT UNSTABLE, LEADING TO THE REMOVAL OF THE SET SCREW FROM THE RIGHT L5 AND INSERTED A NEW SET SCREW. THE SET SCREW CAUGHT AND ENTERED, BUT ACCORDING TO THE SURGEON IT BECAME TIGHT AT AN EARLY STAGE. ANOTHER ATTEMPT WAS MADE WITH THE COUNTER-HEAD, BUT SOMETHING SEEMED OFF. THE COUNTER ALSO FELT LOOSE AND DID NOT SEEM TO BE FULLY INSERTED. AT THAT POINT, ANOTHER SET SCREW WAS INSERTED, BUT AGAIN IT FELT TIGHT MIDWAY. FINALLY, BOTH SCREWS ON THE RIGHT SIDE WERE REMOVED AND REPLACED WITH NEW ONES, ALLOWING THE SET SCREW TO BE INSTALLED WITHOUT ISSUES. COMPRESSION WAS APPLIED, AND THE FINAL THREADING WAS COMPLETED. THERE WAS DELAY OF LESS THAN 60 MINUTES AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE PROCEDURE INVOLVED IN THE EVENT WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1632731 CD HORIZON® SOLERA® SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC MEDICAL COSTA RICA S.R.L. 1664017 1040999W 00643169545571

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown