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

Model Number	46501816
Medical Device Problem Codes	Mechanical Problem (1384); Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
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
Information was received from healthcare provider (hcp) via manufacturer representative regarding product used in l5/s oblique lateral interbody fusion (olif51) spinal therapy for l5/s lumbar canal stenosis (lcs).It was reported that when the oar was inserted, the tip of the oar's nozzle protruded significantly beyond the hole, causing the screw to become loose.There was a delay of less than 60 minutes and no further complications or symptoms reported.The cage was placed between the vertebrae and a pilot hole for the first screw was created using an awl and it felt like the awl protruded deeper than usual.Furthermore, the screw installed in that pilot hole was not effective and was loose, so felt something unusual, so removed the screw, and then removed the cage.When tested outside the surgical field, similarly noticed that the awl protruding deeper than normal.A new cage with a another lot was opened, and the same awl was used, it could be installed without any problems (the cage that was removed the first time was used for the screw).There were no problems were confirmed in the awl itself and poor shape of the cage is suspected.
Event or Problem Description
Additional information was received via manufacturing representative that there is no revision surgery scheduled or planned for the removal of implant.
Additional Manufacturer Narrative
B5 has been updated.D6b.Explant date has been updated.H6: fdm has been 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.
Additional Manufacturer Narrative
H3: product analysis of part# 46501816 lot# tm0141960 after visual and optical examination, there appears to be damage to the screw hole cutouts, however the inner diameter is still to within specification.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: 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: 21736661
• Report Number: 3006340236-2025-00024
• Device Sequence Number: 11764175
• Product Code: MAX
• UDI-Device Identifier: 00763000129859
• UDI-Public: 00763000129859
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K214010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2025

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: 46501816
• Device Catalogue Number: 46501816
• Device Lot Number: TM0141960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 04/07/2025; 06/05/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 05/04/2025; 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2023
• 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
• Patient Sex: Male