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	5166-1405-N
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Date of Event	09/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G2: the country of the event is germany.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 a patient having anterior cervical discectomy and fusion (acdf) procedure at the hwk 3/4 level for an indication of herniated disc at hwk 3/4.It was reported that the cage became loose and slipped, and the patient did not achieve solid fusion.The additional surgery was performed on (b)(6) 2025 to explant the cage.The patient was having slight discomfort when swallowing as a result of this event.
Additional Manufacturer Narrative
Additional information: h11 radiographic image review: the lateral x-ray of c3-4 acdf was provided.The interbody device is translated anteriorly.No fixation device is present.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.
Additional Manufacturer Narrative
Additional information: d9, h3, h6 h3.Device evaluation summary: product analysis # (b)(4): part # 5166-1405-n lot # tm0149328 visual and optical inspection did not reveal any damage to the spacer.Functional inspection confirmed the spacer was able to be attached and release from a sample inserter without any issue.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: 23345589
• Report Number: 3011577940-2025-00015
• Device Sequence Number: 7807068
• Product Code: ODP
• UDI-Device Identifier: 00191375013051
• UDI-Public: (01)00191375013051(17)290801(10)TM0149328
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/15/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5166-1405-N
• Device Catalogue Number: 5166-1405-N
• Device Lot Number: TM0149328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 11/19/2025; 12/11/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/10/2025; 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female