CD HORIZON® SPINAL SYSTEM

Description of Event or Problem

INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WITH CLINICAL ID (b)(4). THE PATIENT WAS REPORTED TO HAVE LOOSENING OF THE L2 SCREWS WITH ONSET DATE OF (b)(6) 2025, RECORDED AS OCCURRING POST-SURGERY. DIAGNOSTIC EVALUATION INCLUDED MRI ON (b)(6) 2025, REPORTED AS CLINICALLY SIGNIFICANT, SHOWING SLIGHT DISPLACEMENT OF THE SCREWS IN L2. THE NARRATIVE STATES THAT SLIGHT DISPLACEMENT OF THE SCREWS IN L2, REMAINING WITHIN THE BONE, WAS FIRST OBSERVED ON POSTOPERATIVE MRI ON (b)(6) 2026 AND CONFIRMED AT SUBSEQUENT FOLLOW-UP VISITS. THE SITE BECAME AWARE OF THE EVENT ON (b)(6) 2026. NO TREATMENT WAS REPORTED, AND NO HOSPITALIZATION OCCURRED. THE EVENT WAS ASSESSED AS NON-SERIOUS, WITH NO DEATH, LIFE-THREATENING EVENT, DISABILITY, HOSPITALIZATION, CONGENITAL ANOMALY, OR MEDICAL/SURGICAL INTERVENTION. THE OUTCOME WAS REPORTED AS NOT RECOVERED/NOT RESOLVED. THE SITE ASSESSED THE EVENT AS NOT RELATED TO THE STUDY DEVICE AND CAUSALLY RELATED TO THE INDEX SURGERY/PROCEDURE. THE SPONSOR ASSESSMENT WAS THE SAME, STATING THE EVENT WAS CAUSALLY RELATED TO THE INDEX PROCEDURE AND NOT RELATED TO THE DEVICE..

Additional Manufacturer Narrative

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.