MAUDE Adverse Event Report: TITAN SPINE ANTERALIGN SPINAL SYSTEM WITH TITAN NANOLOCK; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BOD

Model Number	4675125
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
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 a manufacturer representative regarding a patient having removal of prev ious solera 4.75 instrumentation from l2-5, alif l5-s1, olif l2-3, t10-pelvis pedicle screw rod fixation, l1-2 and l2-3 laminectomy.It was reported that the radiographic imaging revealed that the s1 screw had backed out of the vertebral body and implant.No patient complications have been reported as a result of this event.

• Brand Name: ANTERALIGN SPINAL SYSTEM WITH TITAN NANOLOCK
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BOD
• 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: 22165050
• Report Number: 3006340236-2025-00033
• Device Sequence Number: 9382956
• Product Code: KWQ
• UDI-Device Identifier: 00763000911027
• UDI-Public: 00763000911027
• 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
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2025

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: 4675125
• Device Catalogue Number: 4675125
• Device Lot Number: TM0150828
• 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: 05/14/2025
• Initial Report FDA Received Date: 06/09/2025
• Date Device Manufactured: 11/07/2024
• 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