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	56250905
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having right-sided app roach tilif at l5/s1 for lumbar spinal canal stenosis.It was reported that the inserter did not lock sufficiently when the cage was connected to the inserter and the cage was fixed to the inserter.Joint motion was not controlled even with the clutch handle closed.The cage was changed to a catalift cage.Before insertion of the cage, the trial was used with the same inserter, but there was no problem in grasping.There was a delay of less than 60 minutes in the overall procedure time.The issue occurred during preparation.There was no patient symptom reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
H3: product analysis of part # 56250905, lot # ca19j046; visual and optical inspection did not reveal any thread damage or outer surface damage.Functional inspection confirmed the spacer was able to attach/thread onto the inserter without any issue.No fault found.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.

• 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: 21685621
• Report Number: 1030489-2025-01520
• Device Sequence Number: 9419610
• Product Code: MAX
• UDI-Device Identifier: 00763000085438
• UDI-Public: 00763000085438
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2025

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: 56250905
• Device Catalogue Number: 56250905
• Device Lot Number: CA19J046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2023
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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