MAUDE Adverse Event Report: TITAN SPINE, A DIVISION OF MEDTRONIC ANTERALIGN LS NANO; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BOD

Model Number	4675125
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a screw used for spinal therapy.It was reported that during an anteralign construct procedure at l4-5, two of the 5.0 x 25 mm trocar tip bone screw (the inferior screw into l5) out of six used was backing out.No patient symptoms or complications were reported, and the patient outcome was alive with no injury.No replacement was performed.No patient complications have been reported as a result of this event.Additional information received that initial hospitalization wasn't prolonged, however a second procedure to supplement anterior fixation was performed on (b)(6) 2026.A posterior l4-s1 instrumented fusion with voyager implant system was performed.The procedure involved was l4-s1 alif with anteralign ls implant system.
Additional Manufacturer Narrative
H6: neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.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 LS NANO
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BOD
• Manufacturer (Section D): TITAN SPINE, A DIVISION OF MEDTRONIC; 8347 n steven rd; milwaukee WI 53092
• Manufacturer (Section G): TITAN SPINE, A DIVISION OF MEDTRONIC; 8347 n steven rd; milwaukee WI 53092
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 25514429
• Report Number: 3011577940-2026-00018
• Device Sequence Number: 13400178
• Product Code: KWQ
• UDI-Device Identifier: 00763000911027
• UDI-Public: (01)00763000911027(17)330227(10)TM0152647
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K212524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4675125
• Device Catalogue Number: 4675125
• Device Lot Number: TM0152647
• 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: 05/19/2026
• Initial Report FDA Received Date: 06/16/2026
• Date Device Manufactured: 02/27/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female