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	NAV4680003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a product used for spinal therapy.It was reported that during a spinal procedure, the threaded tip of the inserter broke off during the trialing process, resulting in the trial becoming stuck in-between the l4/5 vertebral bodies.The inserter and trial broke off in the patient at the l4/5 disc space during the procedure.The surgeon was able to remove the trial from the vertebral bodies without incident and subsequently used a different inserter to place the interbody device.There were no patient complications or symptoms have been reported as a result of this event.Additional information was received from manufacturer representative that the reported device has been already used before prior to this event.The threaded part of the inserter broke off into the trial.Trial is now damaged due to the different types of instruments used to dislodge the trial from disc space.The pre-op diagnosis was l4/5 disc degeneration with a grade 1 spondylolisthesis.L4/5 olif was the procedure and l4/5 disc space is where the trial broke off.
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review.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¿ 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: 24587982
• Report Number: 3003120897-2026-00479
• Device Sequence Number: 5688849
• Product Code: MAX
• UDI-Device Identifier: 00763000204334
• UDI-Public: (01)00763000204334(11)211213(10)EM21H055
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/13/2026

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: NAV4680003
• Device Catalogue Number: NAV4680003
• Device Lot Number: EM21H055
• 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: 11/19/2025
• Initial Report FDA Received Date: 03/13/2026
• Date Device Manufactured: 12/13/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female