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	56250805
Medical Device Problem Codes	Use of Device Problem (1670); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a healthcare provider (hcp) via a medtronic representative regarding a patient who was implanted with cage who was suffering from spondylolisthesis.It was reported that the cage was inserted between l4/5 by tlif operation.Levels implanted l4/s.The rotation of cage was checked in the lateral image, but it was shown in a way that was different from usual, so ap was checked.When the inserter was removed and checked at that time, it was confirmed that the cage had dislodged to the lateral side of the vertebral body on the entry (left) side.So an attempt was made to remove it, but the cage gradually moved forward and laterally, and it was determined that removal would be difficult, so it was decided to remove it via an anterior approach at a later date ((b)(6) 2023).Cage remains between l5/s vertebral bodies, near the anterior vertebral wall, and near the iliopsoas muscle.So the patient needed hospitalization or prolonged hospitalization.There was delay in the procedure around less than 60 minutes.No adverse event occurred to patient.There were no further complications that were reported.Additional information received.It was reported that the dislodgement occurred at the l4/5 level, so the implant has not been placed properly.It is confirmed that malfunction occurred due to user error.So additional surgery was performed on (b)(6) 2023 to explant the implant (cage) and it would be discarded at the hospital.
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 16302847
• Report Number: 1030489-2023-00069
• Device Sequence Number: 15151414
• Product Code: MAX
• UDI-Device Identifier: 00763000085421
• UDI-Public: 00763000085421
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171689
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 02/06/2023

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: 56250805
• Device Catalogue Number: 56250805
• Device Lot Number: CA21G104
• 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: 01/10/2023
• Initial Report FDA Received Date: 02/06/2023
• Date Device Manufactured: 03/02/2022
• 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; Hospitalization
• Patient Sex: Unknown