NUMBER:5186-1608-NDESCRIPTION:NANOLOCK, 6 DEG INTERBODY, LARGE, 8MMLIFECYCLE PHA

Additional Manufacturer Narrative

D4: LOT NUM IS UNKNOWN. 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 WITH STUDY ID: (B)(6), PATIENT ID: (B)(6) AND SUBEVENT NUMBER: 001. ONSET DATE: 2026-04-10 DESCRIPTION: LEFT LEG RADICULOPATHY OUTCOME STATUS: RECOVERING / RESOLVING INTERVENTION: ACTION SUBTYPE: HOSPITALIZATION ACTION RESULT: NO ACTION SUBTYPE: AE RESULT IN ANY TREATMENT ACTION RESULT: YES, ACTION SUBTYPE: MEDICATION ADMINISTRATION ACTION RESULT: YES DIAGNOSTIC: ACTION TYPE: DIAGNOSTIC ACTION SUBTYPE: ANY DIAGNOSTIC TESTS PERFORMED ACTION RESULT: THE PATIENT DOES HAVE SUBSIDENCE OF THE INTERBODY GRAFT AT THE SPONDYLOLISTHESIS AT L5-S1. SLIGHT DISPLACEMENT FROM I NTRAOPERATIVE X-RAYS. ACTION DATE: 2026-06-10 SUMMARY: PATIENT IS EXPERIENCING LEFT LEG PAIN THAT SHE WOKE UP WITH POSTOPERATIVELY. IT RUNS DOWN TO THE BUTTOCK AND DOWN THE THIGH INTO THE SHIN. IT IS SHARP AND SHOOTING. PATIENT GETS "CATCHES "MULTIPLE TIMES PER DAY IT HAS GOTTEN BETTER OVER THE PAST MONTH HOWEVER IT IS STILL HAPPENING FREQUENTLY. IT IS WORSE AT NIGHT. THIS ADVERSE EVENT DOES NOT MEET ANY OF THE FOLLOWING SERIOUSNESS CRITERIA: CONGENITAL ANOMALY, DEATH, DISABILITY, HOSPITALIZATION, LIFETHREATENING, MEDICAL/SURGICAL INTERVENTION. SITE RELATED ASSESSMENT: DEVICE STUDY: DEVICE IS NOT RELATED TO THE PROCEDURE. PROCEDURE IDENTIFIED: INDEX SURGERY (PROBABLE) SPONSOR ASSESSMENT (OC MUO): CAUSAL RELATED TO INDEX PROCEDURE, CAUSAL RELATED TO DEVICE. AE DIAGNOSTIC TEST CRF INDICATES SUBSIDENCE OF THE INTERBODY GRAFT. LONG DESCRIPTION: LEFT LEG RADICULOPATHY WITH SUBSIDENCE OF THE INTERBODY GRAFT. RELATED DEVICE: DISPOSITION: IN-USE, NOTES: DEVICE NAME: ENDOSKELETON TC NANOLOCK SITE RELATED ASSESSMENT: DEVICE STUDY: POSSIBLE DESCRIPTION: LEFT LEG RADICULOPATHY NARRATIVE: PATIENT IS EXPERIENCING LEFT LEG PAIN THAT SHE WOKE UP WITH POSTOPERATIVELY. IT RUNS DOWN TO THE BUTTOCK AND DOWN THE THIGH INTO THE SHIN. IT IS SHARP AND SHOOTING. SHE GETS "CATCHES" MULTIPLE TIMES PER DAY. IT HAS GOTTEN BETTER OVER THE PAST MONTH; HOWEVER, IT IS STILL HAPPENING FREQUENTLY. IT IS WORSE AT NIGHT. SUBSIDENCE OF THE INTERBODY GRAFT AT THE SPONDYLOLISTHESIS AT L5-S1 NOTED ON XRAY.