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	5166-1407-N
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a product used in anterior cervi cal discectomy and fusion (acdf) spinal procedure for herniated disc at levels hwk 4/5/6.It was reported that the cages filled with glassbone bioactive bone substitute/injectable putty, the cages became loose and slipped, and no solid fusion was achieved.Additional surgery was performed, during which the cages were removed and replaced.There were no further complications or symptoms as a result of the event.Additional information was received via manufacturer representative that the patient had to undergo further surgery due to secondary bleeding and the resulting paraplegia.According to the surgeon, this was located in the c5/c6 segment.He determined that there was no connection to the ventrally dislocated cage in the c4/c5 segment.The patient unfortunately died on (b)(6) 2025, from multiple organ failure and sepsis.However, according to the surgeon, this was not related with reported products (cages).
Additional Manufacturer Narrative
G2: country of origin 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.
Additional Manufacturer Narrative
Radiographic image assessment concluded that lateral fluoro images shows anterior cervical discectomy and fusion (acdf).Sagittal ct shows interbody graft at c4-5 and c5-6.The c4-5 graft appears anterior.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: 23354888
• Report Number: 3011577940-2025-00017
• Device Sequence Number: 15669397
• Product Code: ODP
• UDI-Device Identifier: 00191375013075
• UDI-Public: (01)00191375013075(17)290919(10)TM0149975
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: 5166-1407-N
• Device Catalogue Number: 5166-1407-N
• Device Lot Number: TM0149975
• 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: 09/25/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 12/16/2025
• Date Device Manufactured: 09/19/2024
• 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: 64 YR
• Patient Sex: Female
• Patient Weight: 185 KG