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	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having spinal therapy for pseudoarthrosis of lumbar spine lumbosacral radiculopathy.It was reported that the surgeon was implanting a cage at l4-5 using the inserter.The cage was loaded in the angled position, and after implantation, the inserter handle did not unscrew easily and produced a squeaking noise followed by a snap.Upon removal, the threaded side of the cage inserter was found to have broken off and remained lodged in the threads of the implanted cage.There was a piece of the threaded inserter still threaded in to the cage.The piece of the inserter is still threaded to the cage and there is no plan to remove.Additionally, the driver had been used many times, was not gripping the screw. there were no patient symptoms reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
H3: product analysis # (b)(4).Part # nav4680003; lot# em21h026.Visual and optical examination identified it appears that part of the tip of the instrument has been broken off.The metal deformation gives indication that the failure was the result of overload.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: 23425410
• Report Number: 3003120897-2025-00474
• Device Sequence Number: 15836857
• Product Code: MAX
• UDI-Device Identifier: 00885074309620
• UDI-Public: (01)00885074309620(11)211029(10)EM21H026
• 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): 10/30/2025

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: NAV4680003
• Device Catalogue Number: NAV4680003
• Device Lot Number: EM21H026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 103 KG