MAUDE Adverse Event Report: TITAN SPINE, A DIVISION OF MEDTRONIC ENDOSKELETON¿ TCS INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED F

Model Number	5302-3514
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis: part# 5302-3514 lot# v88 visual and optical examination identified it appears that part of the tip of the screw has been broken off.The metal deformation gives indication that the failure was the result of overload.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.
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding an event which occurred during a acdf procedure in a patient diagnosed with cervical spondylosis.It was reported that the staple head locking ring was broken and locking failed.Event did not occur due to user issue.There was no patient symptom reported.There were no further complications reported regarding the event.

• Brand Name: ENDOSKELETON¿ TCS INTERBODY SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED F
• 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: 23274314
• Report Number: 3011577940-2025-00014
• Device Sequence Number: 8854331
• Product Code: OVE
• UDI-Device Identifier: 00191375011507
• UDI-Public: (01)00191375011507(11)231020(10)V88
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151596
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5302-3514
• Device Catalogue Number: 5302-3514
• Device Lot Number: V88
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 10/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• 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
• Patient Age: 55 YR
• Patient Sex: Unknown