ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 56250805Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000085421), received between Feb 6, 2023 and Feb 6, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2023Use of Device Problem; Migration; Use of Device Problem; Migration

  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 D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16302847 ↗