ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 56250905Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000085438), received between Apr 8, 2020 and Mar 25, 2025 — classified as 1 injury, 1 malfunction.

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.

• MalfunctionMar 25, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING RIGHT-SIDED APP ROACH TILIF AT L5/S1 FOR LUMBAR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT THE INSERTER DID NOT LOCK SUFFICIENTLY WHEN THE CAGE WAS CONNECTED TO THE INSERTER AND THE CAGE WAS FIXED TO THE INSERTER. JOINT MOTION WAS NOT CONTROLLED EVEN WITH THE CLUTCH HANDLE CLOSED. THE CAGE WAS CHANGED TO A CATALIFT CAGE. BEFORE INSERTION OF THE CAGE, THE TRIAL WAS USED WITH THE SAME INSERTER, BUT THERE WAS NO PROBLEM IN GRASPING. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME. THE ISSUE OCCURRED DURING PREPARATION. 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 21685621 ↗
• InjuryApr 8, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH LUMBAR SPINAL CANAL STENOSIS; AND UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L3-S1. ON AN UNKNOWN DATE, POST-OP, THE CAGE (THAT WAS IMPLANTED AT L3-L4) BACKED OUT FROM THE INTERVERTEBRAL DISC SPACE. ADDITIONALLY, ON BOTH THE LEFT SIDE AND THE RIGHT SIDE, THE RODS HAD DEVIATED FROM THE SCREWS AT L3 TO THE CAUDAL SIDE, BUT THE SET SCREWS REMAINED FITTED ON THE SCREWS. REPORTEDLY, ALTHOUGH, A REVISION SURGERY HAD BEEN SCHEDULED FOR (B)(6) 2020 DUE TO POSTERIOR JUNCTIONAL KYPHOSIS, THE PATIENT DID NOT WANT TO UNDERGO A REVISION SURGERY. SO, THE REVISION SURGERY WOULD NOT BE PERFORMED CURRENTLY. THE SURGEON SUSPECTED THAT THE COMPRESSION LOOSENED DUE TO THE ROD DEVIATED, WHICH LED TO THE RESULT THAT THE CAGE BACKED OUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9933939 ↗