MAUDE Adverse Event Report: TITAN SPINE, A DIVISION OF MEDTRONIC ENDOSKELETON¿ TC INTERBODY SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	5146-1206-N
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stenosis (2263); Spinal Cord Injury (2432)
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Information received from healthcare provider via manufacturer representative regarding a patient with clinical id: (b)(6), study id: (b)(4) and incident type ae subevent number: 001.Primary diagnosis: stenosis onset date: on (b)(6) 2025 outcome date: on (b)(6) 2025 outcome status: recovered/ resolved interventions: action subtype: hospitalization action result: new hospitalization action date: on (b)(6) 2025 hospitalization end date: on (b)(6) 2025 action subtype: ae result in any treatment action result: yes action subtype: medication administration action result: yes any of these opiates or narcotics (adjusted or administered): no site seriousness assessment: there is hospitalization and no congenital anomaly, death, disability, life threatening, medical or surgical intervention.Site related assessment: it is not related to study device and possible related to study procedure (index surgery).Diagnostics: action type: diagnostic action subtype: diagnostic tests performed action result: no event: it was reported that the patient had cervical myelopathy, neck pain with severe stenosis at c5-7, nonunion, flatneck.Failed conservative management therefore in the outpatient setting elected proceed with cervical decompression fusion.Patient was stabilized and symptoms were recovered, hence discharged from hospital.Additional information was received that sponsor assessment (oc muo): possible related to study device and not related to procedure.Additional information was received that description 1: cervical spondylotic myelopathy interventions: action subtype: hospitalization action result: new hospitalization action date: on (b)(6) 2025 hospitalization end date: on (b)(6) 2025 action subtype: ae result in any treatment action result: yes action subtype: medication administration action result: yes any of theseopiates or narcotics (adjusted or administered): no action subtype: spinal surgery action result: yes specify the additional spinal surgery additional spinal surgery, on (b)(6) 2025.
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.

• Brand Name: ENDOSKELETON¿ TC INTERBODY SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): TITAN SPINE, A DIVISION OF MEDTRONIC; 8347 n steven rd; milwaukee WI 53092
• Manufacturer (Section G): TITAN SPINE, A DIVISION OF MEDTRONIC; 8347 n steven rd; milwaukee WI 53092
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 24625432
• Report Number: 3011577940-2026-00008
• Device Sequence Number: 15691705
• Product Code: ODP
• UDI-Device Identifier: 00191375012986
• UDI-Public: (01)00191375012986(17)280714(10)TM0143950
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K141953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 5146-1206-N
• Device Catalogue Number: 5146-1206-N
• Device Lot Number: TM0143950
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/18/2026
• Date Device Manufactured: 07/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White