BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SOLERA¿ FENESTRATED SCREW SPINAL SYSTEM

    MDR report key: 22177166 · Received June 10, 2025

    Report

    Report Number
    1030489-2025-02192
    Event Type
    Malfunction
    Date Received
    June 10, 2025
    Date of Event
    May 12, 2025
    Report Date
    August 18, 2025
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    UDI-DI
    00763000197605
    PMA / PMN Number
    SEE H11
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG# 55840027545T, 510K# K152604 AND UDI# (B)(4) WAS CLEARED IN THE 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

    RADIOGRAPHIC IMAGE REVIEW: : IMAGE 1- LATERAL X-RAY POSTERIOR THORACIC FUSION LEVELS UNKNOWN. AT SECOND LEVEL FROM TOP THREE APPEARS TO BE A RETAINED SCREW FRAGMENT. IMAGE 2- LATERAL VIEW OF IMAGE 1. 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: PART # 55040024545, LOT # H5980328 VISUAL AND OPTICAL INSPECTION DID NOT REVEAL ANY DEFECTS IN THE SCREW THAT COULD CONTRIBUTE TO THE SCREW BREAKING. OPTICAL INSPECTION REVEALED THE UPPER TIP OF THE SCREW SHANK HAS BROKEN. THE DAMAGE TO THE SCREW IS CONSISTENT WITH OVERLOAD AS THE MECHANISM OF FAILURE. 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 A HEALTHCARE PROFESSIONAL REGARDING A PATIENT HAVING TUMOR BRIDGING FOR TUMOR T10 AND RESECTION DUE TO T10 TUMOR. IT WAS REPORTED THAT THE LOWER THREAD OF THE SCREW HAS BROKEN OFF AND REMAINED IN THE PATIENT. WHILE ATTEMPTING TO SCREW IN THE 4.5 X 45 MM SCREW INTO A VERY HARD BONE AFFECTED BY OSTEOBLASTIC METASTASIS, THE SCREW SUDDENLY BROKE WITHOUT EXPERIENCING AN EXCESSIVELY LARGE TORQUE DURING INSERTION. THE SCREW PLACEMENT WAS OPTIMAL, AND THE SCREW WAS ALREADY 2/3 IMPLANTED, LEAVING ABOUT A 1 CM LONG PIECE OF THE SCREW REMAINING IN THE VERTEBRAL BODY. THE SCREW HEAD WITH THE REMAINING THREAD HAS BEEN REMOVED. NORMALLY THE PATIENT SHOULD BE SCREWED UP TO TH9 (RIGHT), BUT AS THE SCREW FRACTURE OCCURRED IN TH9, THE SURGEON HAD TO SCREW ANOTHER SEGMENT (TH8). THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1632662 CD HORIZON® SOLERA¿ FENESTRATED SCREW SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MDT SOFAMOR DANEK PUERTO RICO MFG 55040024545 H5980328 00763000197605

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Unknown Required Intervention