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

Catalog Number	56251105
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Radiographic image review result: post-op x-ray ap / lateral provided for l4-5, fusion.A peak spacer at l4-5 appears in good position but the cage at l5-s appears to be position to the back of the vertebral body at l5.Views of the original position at surgery are not provided and fusion status is unknown.Hardware placement otherwise appears appropriate.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent open surgery at l4/5/s due to lcs (lumbar canal stenosis) and adjacent segment disease.Post-op, cage backed out.Hence on an (b)(6) 2020, a revision surgery was performed in which removal of cage implanted at l5/s done.The crosslink and rod were removed.Removing cage at l5/s was performed from the left side successfully with specific instrument for removal.For l5/s, the bone from the iliac bone was transplanted into the intervertebral disc space.The rod and crosslink was inserted and wound closure was performed.There was no delay in overall procedure time and no other patient symptoms or complications reported as a result of this event.

• Brand Name: ARTIC-L 3D TI SPINAL SYSTEM WITH TIONIC TECHNOLOGY
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10173078
• Report Number: 1030489-2020-00667
• Device Sequence Number: 11665444
• Product Code: MAX
• UDI-Device Identifier: 00763000085452
• UDI-Public: 00763000085452
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/19/2020

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 Catalogue Number: 56251105
• Device Lot Number: CA18E044
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 06/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention