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

Model Number	84332409
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G4: product identifiers unknown.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 health care provider via manufacturing representative regarding a patient undergone spinal therapy.It was reported that planned revision surgery on (b)(6) 2025.No information has been provided about the assessment as device or procedure related.No further complications reported/anticipated.Additional information received from the rep that this patient had a pseudoarthrosis with cage subsidence, and would not consider this an issue with the implants but a failure to health secondary to osteopenia and malnutrition in her case.Safety is attempting to gain additional information from the site to confirm whether a device related event or device deficiency occurred, at this time investigator assessment is not related to procedure or device.
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.
Event or Problem Description
Additional information was received from the rep that "corresponding procedure utilized/ implanted index surgery, (b)(6) 2024 spinal level where treatment started was l4 and ended l5.Corresponding procedure explanted (1) additional spinal surgery, (b)(6) 2025.

• Brand Name: ADAPTIX¿ 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 TN 53092
• Manufacturer (Section G): TITAN SPINE, A DIVISION OF MEDTRONIC; 8347 n steven rd; milwaukee,wi TN 53092
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 22870298
• Report Number: 3003120897-2025-00112
• Device Sequence Number: 18412381
• Product Code: MAX
• UDI-Device Identifier: 00763000202880
• UDI-Public: (01)00763000202880(17)311103(10)TM0144491
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K201267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2025

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: 84332409
• Device Catalogue Number: 84332409
• Device Lot Number: TM0144491
• 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: 07/28/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 12/24/2025
• Date Device Manufactured: 11/03/2023
• 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: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 49 KG