MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. ARTIC-L¿ 3D TI SPINAL SYSTEM WITH TIONIC¿ TECHNOLOGY; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

Model Number	56251210
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
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 obtained from healthcare professional via manufacturer representative regarding an implant used for spinal therapy.It was stated that the patient underwent surgery on (b)(6) 2026 and came back on (b)(6) 2026 reporting pain after surgery.A x-ray was performed through which doctor found the cage to be dislocated.No further complications were reported regarding this event.Procedure involved was posterior decompression and instrumented fusion performed on (b)(6) 2026 at the l4-s1 level.The reported product was implanted at the l5-s1 levels; which is where the dislocation occurred.Revision surgery was performed on (b)(6) 2026 for relocation.

• Brand Name: ARTIC-L¿ 3D TI SPINAL SYSTEM WITH TIONIC¿ 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: 24726460
• Report Number: 3003120897-2026-00593
• Device Sequence Number: 10421580
• Product Code: MAX
• UDI-Device Identifier: 00763000085704
• UDI-Public: (01)00763000085704(17)300502(10)CA21J029
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K171689
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

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: 56251210
• Device Catalogue Number: 56251210
• Device Lot Number: CA21J029
• 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: 03/10/2026
• Initial Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 05/02/2022
• 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: 74 YR
• Patient Sex: Male