MAUDE Adverse Event Report: TITAN SPINE 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 Codes	Fatigue (1849); Pain (1994); Burning Sensation (2146); Ambulation or Postural Difficulties (2544)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6 - neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.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 multiple sources (manufacturer representative, healthcare provider, clinical study) regarding an event which occurred post a clinical study (study id: (b)(6) l4-l5 tlif procedure in a patient (patient id: (b)(6).It was reported that patient describes burning sensation in left leg which leads to fatigue and the feeling of inability to lift it.Pain is present in same space that was present prior to surgery.Patient finds it challenging to walk.As per sponsor assessment event is possibly related to procedure and intervertebral body fusion device.Not related to tlif grafting material and posterior supplemental fixation system. there were no further complications reported regarding the event.
Additional Manufacturer Narrative
B5: event details updated 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
Description: lumbar pseudoarthrosis subsidence of tlif cage patient medical history: high cholesterol, hypertension, acid reflux, arthritis, l4-l5 decompression, lumbar radiculopathy, lumbar spondylosis w/ radiculopathy, spinal stenosis w/ neurogenic claudication, hysterectomy, tonsillectomy, decompression (start date: (b)(6) 2023; spinal level: l4-l5), primary diagnosis: stenosis, substance use: nicotine.

• Brand Name: ADAPTIX¿ INTERBODY SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): TITAN SPINE; 6140 w. executive dr. suite a; mequon WI 53092
• Manufacturer (Section G): TITAN SPINE; 6140 w. executive dr. suite a; mequon WI 53092
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 20862368
• Report Number: 3006340236-2024-00016
• Device Sequence Number: 18298247
• Product Code: MAX
• UDI-Device Identifier: 00763000202880
• UDI-Public: 00763000202880
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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: 84332409
• Device Catalogue Number: 84332409
• Device Lot Number: TM0140491
• 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: 11/12/2024
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 02/03/2026
• Date Device Manufactured: 11/21/2022
• 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: 68 YR
• Patient Sex: Female
• Patient Race: White