BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 23357452 · Received October 22, 2025

    Report

    Report Number
    2647346-2025-00165
    Event Type
    Injury
    Date Received
    October 22, 2025
    Date of Event
    September 30, 2025
    Report Date
    January 7, 2026
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    NKB
    UDI-DI
    00643169261617
    PMA / PMN Number
    SEE H11
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 # 1555006100, 510K # K121680 AND UDI # (B)(4). WAS CLEARED IN THE UNITED STATES. E1: FIRST NAME AND LAST NAME OF INITIAL REPORTER IS UNKNOWN. B2: OUTCOME ATTRIBUTED TO ADVERSE EVENT IS ADDITIONAL SURGERY AND HOSPITALIZATION. 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 STATES, ANTEROPOSTERIOR LATERAL XRAY L2-5 INTERBODY FUSION GRAFTS WERE PRESENT AT LEVELS L2-3, L3-4, L4-5. ANTEROPOSTERIOR LATERAL XRAY, THE SET SCREW AT L2 AND L5 APPEAR DISLODGED IN (1) COMPARED TO (2). PRE-OP ANTEROPOSTERIOR LATERAL XRAY. 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:1555106110, LOT:1026805W. AFTER VISUAL AND OPTICAL EXAMINATION AND FUNCTIONAL TESTING, IT DOES NOT APPEAR TO BE ANY DAMAGE, NOR DOES IT INDICATE ANY FUNCTIONAL ISSUES WITH THE ROD. 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 POSTERIOR FIXAT ION WAS PERFORMED FOLLOWING L2/5 XLIF, WITH FNS MAS USED FOR CEMENT AUGMENTATION AT L2 AND L5 FOR KYPHOSIS. IT WAS REPORTED THAT THREE MONTHS AFTER INITIAL SURGERY, THREE SET SCREWS BECAME DISLODGED ON THE LEFT SIDE OF L2 AND BOTH SIDES OF L5, RESULTING IN LOWER BACK AND LOWER LIMB PAIN AND REQUIRING REPEAT SURGERY. DURING THE REPEAT PROCEDURE, THE DISLODGED SCREWS AND RODS WERE EXPLANTED AND REPLACED, AND THE PATIENT WAS HOSPITALIZED FOR THIS INTERVENTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242382 CD HORIZON® SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MDT PUERTO RICO OPERATIONS CO, MED REL 1555106110 1026805W 00643169261617

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H