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

Model Number	84332406
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a healthcare professional via a manufacturer representative regarding a patient with preoperative diag nosis for l5/s stenosis.Procedure performed was tlif.Level at which the implant performed was l5/s.It was reported that after inserting the cage, the inserter was tried to remove, but it was difficult to remove as the inner shaft was hard to rotate, so the cage was removed.After the cage was removed from the inserter and when it was tried to install again to the inserter, it could be installed without any problems.So a new cage was opened, installed to the inserter again, and inserted.After insertion, it was the same, the rotation of inner shaft was hard but it could be removed somehow, so the cage was implanted as it is.The intervertebral space was narrow.
Additional Manufacturer Narrative
H3: product analysis of part # 84332406 ; lot # tm0129913 visual and optical inspection did not reveal any damage to the spacer.Functional inspection confirmed the spacer was able to attach and thread onto the inserter and inserter shaft.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.

• 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: 21500944
• Report Number: 3006340236-2025-00015
• Device Sequence Number: 14578152
• Product Code: MAX
• UDI-Device Identifier: 00763000202859
• UDI-Public: 00763000202859
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2025

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: 84332406
• Device Catalogue Number: 84332406
• Device Lot Number: TM0129913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 03/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2020
• 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