CD HORIZON® SPINAL SYSTEM

Additional Manufacturer Narrative

H6: NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. 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

INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT LOW BACK PAIN WITH LEFT SIDED RADICULOPATHY. INTERVENTIONS: THE ADVERSE EVENT RESULTED IN HOSPITALIZATION FROM (B)(6) 2026 AND WAS NOT A PROLONGATION OF AN EXISTING HOSPITALIZATION. TREATMENT WAS PROVIDED, WITH NO OTHER ACTIONS TAKEN. MANAGEMENT INCLUDED HOME EXERCISE, INJECTIONS, AND SURGICAL TREATMENT. THE REPORTED INJECTIONS WERE AN L4-L5 LUMBAR EPIDURAL STEROID INJECTION ON (B)(6) 2026, WHICH FAILED, AND A LEFT L5 SELECTIVE NERVE ROOT INJECTION ON (B)(6) 2026 AT L4-L5, WHICH WAS NOTED AS DIAGNOSTIC POSITIVE. THE OUTCOME WAS REPORTED AS RECOVERING OR RESOLVING. DIAGNOSTICS: DIAGNOSTIC TESTING WAS PERFORMED AND INCLUDED AN MRI WITHOUT CONTRAST, WHICH SHOWED ADJACENT SEGMENT DISEASE. ADDITIONAL DIAGNOSTIC PROCEDURES INCLUDED A LUMBAR EPIDURAL STEROID INJECTION, WHICH WAS REPORTED AS FAILED, AND A LEFT L5 SELECTIVE NERVE ROOT INJECTION, WHICH WAS NOTED AS DIAGNOSTICALLY POSITIVE. OVERALL, DIAGNOSTIC EVALUATION WAS CONFIRMED AS PERFORMED. COMMENTS: THE ADVERSE EVENT INVOLVED THE LUMBOSACRAL SPINE, SPECIFICALLY AT THE L4-L5 LEVEL. AN ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2026 INVOLVING THE L4-L5 SPINAL LEVEL. THE PROCEDURE INCLUDED L4-L5 DECOMPRESSION AND INSTRUMENTED POSTEROLATERAL LUMBAR FUSION, REMOVAL AND INSTRUMENTATION AT L5-S1, INSPECTION OF THE L5-S1 FUSION, AND REVISION INSTRUMENTATION FROM L4-S1. THIS WAS REPORTED AS AN ELECTIVE REMOVAL DUE TO ADJACENT SEGMENT DEGENERATION, WITH CONFIRMATION THAT THE INDEX TREATED LEVELS HAD BEEN FUSED PRIOR TO REMOVAL OF THE FIXATION COMPONENT FROM THE ORIGINAL SURGICAL CONSTRUCT. THE PROCEDURE ALSO INVOLVED AN EXPLANT RELATED TO THE STUDY PROCEDURE, WITH THE CAUSE OF EXPLANTATION DESCRIBED AS REVISION OF THE L4-S1 RODS FROM 5.5 X 35 MM TO 5.5 X 50 MM. AT THE ADDITIONAL SURGERY, NO SPECIFIC FINDINGS RELATED TO EXPLANTATION WERE REPORTED, AND THE EXPLANT WAS PERFORMED TO EXTEND THE INSTRUMENTATION TO THE NEW SURGICAL LEVEL. SURGICAL FINDINGS INCLUDED AN L4-L5 HERNIATED NUCLEUS PULPOSUS, AND NO BIOPSIES WERETAKEN. NARRATIVE: SECONDARY TO ADJACENT SEGMENT DISEASE PROGRESSION AT L4-L5 WITH MILD TO MODERATE RIGHT SIDED NEURO FORAMINAL STENOSIS NOW WORSENED LUMBAR MRI 04/03/26, MEDICATIONS, L4-L5 LUMBAR EPIDURAL STEROID INJECTION (B)(6) 2026, LEFT L5 SELECTIVE NERVE ROOT INJECTION DX+ SURGICAL INTERVENTION WITH THE PI, L4- L5 DECOMPRESSION POSTEROLATERAL FUSION AND REMOVAL ON INSTRUMENTATION AT L5-S1 AND REVISION INSTRUMENTATION TO L4-S1 (ROD ONLY) ON (B)(6) 2026 DISCHARGED FROM INPATIENT STAY ON (B)(6) 2026. SITE SERIOUSNESS ASSESSMENT: THE ADVERSE EVENT WAS ASSESSED AS SEVERE AND MET THE SERIOUSNESS CRITERION OF HOSPITALIZATION. IT WAS NOT ASSOCIATED WITH CONGENITAL ANOMALY, DEATH, DISABILITY, A LIFE-THREATENING CONDITION, OR THE NEED FOR MEDICAL INTERVENTION. SITE RELATED ASSESSMENT: THE ADVERSE EVENT AND ADDITIONAL SURGERY WERE ASSESSED AS NOT RELATED TO THE STUDY DEVICES OR STUDY PROCEDURE. SPECIFICALLY, THE CAPSTONE PEEK SPINAL SYSTEM IMPLANT, THE POSTERIOR SUPPLEMENTAL FIXATION SYSTEM, AND THE TLIF GRAFTING MATERIAL WERE EACH CONSIDERED NOT RELATED. THE ADDITIONAL SURGICAL PROCEDURE WAS ALSO ASSESSED AS NOT RELATED TO THE STUDY PROCEDURE. SPONSOR ASSESSMENT (OC MUO): SPONSOR ASSESSED AS POSSIBLE RELATED TO POSTERIOR SUPPLEMENTAL FIXATION SYSTEM. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EXPLANT OF THE RODS WAS DONE TO EXTEND INSTRUMENTATION TO NEW SURGERY LEVEL.