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	56300805
Medical Device Problem Codes	Product Quality Problem (1506); Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter details are unknown g2: country of origin - japan h3: product analysis: product id# 56300805; lot# ca20c052 visual and microscopic examination revealed the spacer has some witness marks on the nose of the attachment point and thread crest and flank damage; this damage appears to have initiated at the start of the thread and is consistent around the damaged portion of the threads.This type of damage is consistent with misalignment.This regulatory report is being submitted due to retrospective review through capa 624392.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 tlif for an ind ication of lumbar stenosis.It was reported that when attaching the artic to the inserter, the tip of the inserter could only be inserted about half way and could not be properly attached.The same size was opened in another one, but it could not be attached for the same reason.The product did not come in contact with the patient.There were no patient symptoms reported.There were no further complications reported regarding the event.

• 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: 21055476
• Report Number: 1030489-2025-00022
• Device Sequence Number: 15647119
• Product Code: MAX
• UDI-Device Identifier: 00763000085506
• UDI-Public: 00763000085506
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171689
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/02/2025

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: 56300805
• Device Catalogue Number: 56300805
• Device Lot Number: CA20C052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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: Unknown