ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 56300905Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000085513), received between Mar 12, 2025 and Sep 2, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A SPACER HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE IMPLANT COULD NOT BE PROPERLY CLAMPED INTO THE CAGE HOLDER DURING A T-LIF PROCEDURE. THE IMPLANT KEPT SLIPPING OUT OF PLACE, MAKING IT IMPOSSIBLE TO POSITION IT CORRECTLY IN THE CAGE HOLDER. THE IMPLANT WAS NOT IMPLANTED OR CONNECTED TO A PATIENT AND THE PRODUCT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22937560 ↗
• MalfunctionMar 12, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) PROCEDURE. IT WAS REPORTED THAT IMPLANT WOULD NOT CONNECT TIGHTLY TO INSERTER AND WOULD CONTINUE TO ROTATE DESPITE BEING FULLY-THREADED. INSERTER WAS CHECKED FOR ISSUES AND THERE WERE NONE. HE IMPLANT WAS PARTIALLY INSERTED INTO THE DISC SPACE BUT DUE TO LOOSENESS, AND PRIOR TO ARTICULATION, IT WAS DECIDED BY HCP TO FULLY REMOVE AND PROCEED INSTEAD WITH STRAIGHT, STATIC PEEK BULLET CAGE, CAPSTONE PTC. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583647 ↗