ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 5330009 (UDI 00763000085919)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00763000085919), received between May 31, 2022 and Sep 25, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (5 reports).

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Mechanics Altered

  Information was received from user facility via manufacturing representative regarding a product identified during an event. It was reported that Instrument won't engage. No patient was involved in this event. No further complications were reported/anticipated.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895304 ↗
• MalfunctionJul 31, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50096467 ↗
• MalfunctionMar 12, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF. IT WAS RE PORTED THAT INSERTER DID NOT TIGHTENED ONTO IMPLANT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24577489 ↗
• MalfunctionMar 11, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED PRIOR TO USE. IT WAS REPORTED THAT THE THREADS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567149 ↗
• MalfunctionMar 11, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION(TLIF) L2-4. IT WAS REPORTED THAT THE INSERTERS WERE ALLOWING THE IMPLANT TO STILL MOVE WHEN LOCKED DOWN. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24566243 ↗
• MalfunctionMar 11, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION(TLIF) L2-4. IT WAS REPORTED THAT THE INSERTERS WERE ALLOWING THE IMPLANT TO STILL MOVE WHEN LOCKED DOWN. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24566237 ↗
• MalfunctionFeb 6, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING A TRANSFORAMINAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT THE INSERTERS WOULD NOT STAY THREADED TIGHT TO THE IMPLANT. NO PATIENT SYMPTOMS OR COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277129 ↗
• MalfunctionJan 6, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL REGARDING A PATIENT HAVING L4-S1 TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) . IT WAS REPORTED THAT INSERTER WAS DIFFICULT TO LOAD AND DIDN¿T HOLD IMPLANT TIGHT. 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 23972036 ↗
• MalfunctionJul 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION BETWEEN 1 VERTEBRA. IT WAS REPORTED THAT, THE BALL PORTION ON THE UPPER PART OF THE INSERTER SHAFT WAS DISCONNECTED BEFORE USING IT ON THE PATIENT, SO ANOTHER INSERTER SHAFT WAS USED, AND THE SURGERY WAS CONTINUED. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584780 ↗
• MalfunctionDec 6, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGONE SPINAL THERAPY. IT WAS REPORTED THAT INSERTER TIP BROKE OFF INSIDE OF THE IMPLANT WHEN ATTEMPTING TO BACKSLAP THE IMPLANT OUT TO REPOSITION IT. ALL PIECES WERE RETRIEVED. NO PATIENT SYMPTOMS WERE REPORTED/ANTICIPATED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. PROCEDURE USED WAS L3-S1 MINIMALLY INVASIVE TLIF, ISSUE OCCURRED AT THE L5/S1 LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20862395 ↗
• MalfunctionFeb 22, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A SHAFT INSERTER HAVING SPINAL THERAPY. IT WAS REPORTED THAT AFTER IMPLANTING THE CAGE, THE SURGEON WASN¿T ABLE TO DISCONNECT THE INSERTER FROM THE CAGE USING THE WHEEL ON THE HIND OF THE INSERTER. EVENTUALLY, BY ROTATING THE ENTIRE HANDLE, THE INSERTER WAS DISCONNECTED.  THE INSERTER HANDLE ON THE BACK TABLE WAS INSPECTED AND WHEN THE INNER STYLET WAS REMOVED THE SMALL BALL BEARING AT THE TOP OF THE STYLET FELL OUT. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE INSTRUMENT BROKE AND BALL BEARING IN DISTAL END OF THE STYLET CAME DISLODGED. BALL BEARING FELL OUT OF INSERTER HANDLE ON BACK TABLE, NO COMPONENT/FRAGMENT REMAINED IN PATIENT. PRODUCT CAME IN CONTACT WITH THE PATIENT. PROCEDURE INVOLVED WAS L2-L5 OBLIQUE LATERAL INTERBODY FUSION (OLIF), L5-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AND T10-S2AI POSTERIOR FUSION. PATIENT WAS DOING WELL. THERE WAS NO REVISION SURGERY PLANNED/ OCCURRED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18755883 ↗
• MalfunctionNov 20, 2023Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING INSERTERS IN A TLIF FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT THE INSERTERS' DIDN¿T TIGHTLY ATTACH TO IMPLANT AND THEY HAD DIFFICULTY ROTATING THE IMPLANT COMPLETELY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THE INSERTERS WERE USED ON THE PATIENT DURING PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18168174 ↗
• MalfunctionAug 21, 2023Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR L4-5 DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT, THE ARTICULATING INSERTER WOULD NOT STAY RIGID DURING INSERTION. THE IMPLANT WAS SECURED FULLY ON THE IMPLANT AND IT WOULD TURN TOWARDS THE SPINAL CANAL. THERE WAS DELAY OF 45MIN DUE TO IMPLANT TURNING TOWARDS THE SPINAL CANAL. THERE WERE NO PATIENT SYMPTOMS REPORTED, NO ADDITIONAL TREATMENT OR SURGERY PERFORMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17583793 ↗
• MalfunctionMay 31, 2022Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY DUE TO DEGENERATIVE DISC DISEASE AND SCOLIOSIS. IT WAS REPORTED THAT WHEN THE SURGEON WAS IMPLANTING CAGE HE FELT HE HAD ADVANCED IT TOO FAR. HE ATTACHED SLAP HAMMER ON HIND OF INSERTER TO PULL IT BACK BUT WAS UNSUCCESSFUL BECAUSE CAGE HAD UNEXPECTEDLY DISENGAGED. CAGE WENT TOO FAR ANTERIOR TO SAFELY EXPLANT SO HE FINISHED POSTERIOR PORTION OF SURGERY, FLIPPED PATIENT SUPINE AND PERFORMED ANTERIOR EXPOSURE TO EXPLANT IMPLANT. THE INSERTER RELEASED THE CAGE WITHOUT LOOSENING THE APPROPRIATE RELEASE MECHANISM. INSERTERS CAME IN CONTACT WITH PATIENT. 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 14545971 ↗