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

Model Number	53401825
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis #(b)(4):part # 53401825: lot # ca18h024 visual and optical inspection confirmed the inner threads of the spacer have been damaged.The broken inserter tip was not returned in the spacer.The damage to the implant appears to be from the removal/repositioning process.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 health care provider via manufacturing representative regarding a patient undergone spinal therapy.It was reported that inserter tip broke off inside of the implant when attempting to backslap the implant out to reposition it.All pieces were retrieved.No patient symptoms were reported/anticipated.No further complications were reported/anticipated.Procedure used was l3-s1 minimally invasive tlif, issue occurred at the l5/s1 level.

• Brand Name: ARTIC-XL¿ 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: 20862328
• Report Number: 1030489-2024-01638
• Device Sequence Number: 21029122
• Product Code: MAX
• UDI-Device Identifier: 00643169800526
• UDI-Public: 00643169800526
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171689
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2024

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: 53401825
• Device Catalogue Number: 53401825
• Device Lot Number: CA18H024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 12/06/2024
• 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 Age: 76 YR
• Patient Sex: Male