MAUDE Adverse Event Report: TITAN SPINE ANTERALIGN¿ SPINAL SYSTEM WITH TITAN NANOLOCK¿; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	46261255
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G2: country of origin - japan h3: product analysis #(b)(4):part # 46261255, lot # tm0134886 visual inspection did not reveal any damage to the spacer.Functional inspection with a sample inserter confirmed the spacer was able to attach securely to the instrument.The implant functions as intended.No fault found.This regulatory report is being submitted due to retrospective review through capa 624392.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 a healthcare professional (hcp) via a manufacturer representative regarding a patient undergoing oblique lateral interbody fusion at levels l3/4, 4/5 for spinal canal stenosis.It was reported that cage was placed anteriorly during the l4/5 olif.At that time, there was a cage in front of the body from the anterior surface of the vertebral body.When re-insertion was attempted, loosening was confirmed.It was replaced with 14 mm, however, slight looseness was a concern.It was determined that there were no problems if compression was applied in the back because the bone spur was strong, and the anteralign plate/screw could not be used.There was a delay of less than 60 minutes in the overall procedure time.There were no patient symptoms or complications as a result of this event.No further complications were reported/anticipated.

• Brand Name: ANTERALIGN¿ SPINAL SYSTEM WITH TITAN NANOLOCK¿
• 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: 21075841
• Report Number: 3006340236-2025-00001
• Device Sequence Number: 6899089
• Product Code: MAX
• UDI-Device Identifier: 00763000128548
• UDI-Public: 00763000128548
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K212524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/05/2025

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: 46261255
• Device Catalogue Number: 46261255
• Device Lot Number: TM0134886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 01/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2021
• 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 Sex: Unknown