BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 21502392 · Received March 3, 2025

    Report

    Report Number
    1030489-2025-01096
    Event Type
    Malfunction
    Date Received
    March 3, 2025
    Date of Event
    February 6, 2025
    Report Date
    June 12, 2025
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: THIS DEVICE IS NOT MARKETED IN UNITED STATES BUT HOWEVER, SIMILAR DEVICE WITH PRODUCT# 54740105535, UDI (B)(4), 510(K)# K112555 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

    H3: PRODUCT ANALYSIS: PART # 54790016545, LOT # H5951244. VISUAL INSPECTION DID NOT REVEAL ANY DAMAGE TO THE SCREW. FUNCTIONAL INSPECTION CONFIRMED THE SCREW WAS ABLE TO ATTACH AND DETACH TO A SAMPLE DRIVER WITHOUT ANY ISSUE. NO FAULT FOUND. 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 AN EVENT WHICH OCCURRED DURING A L5/S TLIF PROCEDURE IN A PATIENT DIAGNOSED WITH L5/S VERTEBRAL FORAMEN STENOSIS. IT WAS REPORTED THAT WHEN THE DEVICE (RMAS) WAS ATTACHED TO THE LOCK SLEEVE SCREWDRIVER AS THE LEFT-SIDE PS, THE SCREW COULD NOT BE ATTACHED COAXIAL WITH THE DRIVER. THE DEVICE WAS REPLACED WITH A NEW SCREW, AS ONLY INSTALLATION COULD BE PERFORMED WITH THE DEVICE BENT WITHOUT BEING COAXIAL. THE T25 OF THE SCREW CORE REGION IS BELIEVED TO BE DEFORMED, SO AN INSPECTION IS REQUESTED. 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
    1188566 CD HORIZON® SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MDT SOFAMOR DANEK PUERTO RICO MFG 54790016545 H5951244

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown