MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. ANTERALIGN¿ SPINAL SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	4680005
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/02/2026
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 a manufacturer representative regarding a patient having oblique lumbar interbody fusion.It was reported that, as the trial was being inserted the surgeon felt/heard something break and went to remove the trial to find that the threaded tip of the inserter had broken off inside the trial and the trial was in the disc space and no longer attached to the inserter and the threaded hole was now blocked with the broken tip of the inserter.The threaded shaft was bent in the process of trying to thread in to the unblocked hole of the trial that was inside of the patient to assist in the removal of the trial that was stuck due to the breaking of the threaded tip of the inserter the trial broke off the inserter while inserted in the disc space.Attempts were made to remove it with a kocher, a anteralingn threaded shaft in the unblocked threaded hole (made difficult by position and patient anatomy).Surgeon removed bone from the lateral aspect of the vertebral bodies and was able to grip the trial and remove with a long kocher.This added about 30 minutes to the patients procedure.There were no patient symptoms reported.There were no further complications reported regarding the event.

• Brand Name: ANTERALIGN¿ SPINAL SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC.; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 24468552
• Report Number: 3003120897-2026-00316
• Device Sequence Number: 9615773
• Product Code: MAX
• UDI-Device Identifier: 00763000193942
• UDI-Public: (01)00763000193942(11)220220(10)0011175600
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K212524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2026

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: 4680005
• Device Catalogue Number: 4680005
• Device Lot Number: 0011175600
• 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: 02/02/2026
• Initial Report FDA Received Date: 02/27/2026
• Date Device Manufactured: 02/20/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 83 KG