ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 5330008Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00763000085902), received between Mar 23, 2022 and Mar 11, 2026 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (11 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• 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.DDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE THERAPY INVOLVED IS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24573705 ↗
• MalfunctionFeb 6, 2026Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE SHAFT OF THE INSERTER WAS BROKEN AND THE OTHER DEVICES WERE ALSO BROKEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277383 ↗
• MalfunctionJan 4, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT, THE INSTRUMENT'S CLUTCH HAS BECOME LOOSE. A SCREW HAS BECOME LOOSE ON THE CLUTCH AS IT SLIPS TO THE SIDE WHEN RELEASED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23953820 ↗
• MalfunctionJan 4, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT, THE INSTRUMENT'S CLUTCH HAS BECOME LOOSE. A SCREW HAS BECOME LOOSE ON THE CLUTCH AS IT SLIPS TO THE SIDE WHEN RELEASED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23953817 ↗
• MalfunctionNov 24, 2025Mechanical Problem; Mechanical 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 23628744 ↗
• MalfunctionNov 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER EXPERIENCED INSTRUMENT BREAKAGE WHEN THE INSERTER BROKE AND THE PINS IN THE INSERTERS WERE BACKING OUT. THE LOOSE PIECE WAS IDENTIFIED BEFORE USE, AND NO PATIENT WAS INVOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT FOR THE FIRST INSERTER ALSO, THE PIN WAS BACKING OUT MAKING GRIP HANDLE LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23590497 ↗
• MalfunctionNov 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER EXPERIENCED INSTRUMENT BREAKAGE WHEN THE INSERTER BROKE AND THE PINS IN THE INSERTERS WERE BACKING OUT. THE LOOSE PIECE WAS IDENTIFIED BEFORE USE, AND NO PATIENT WAS INVOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT FOR THE FIRST INSERTER ALSO, THE PIN WAS BACKING OUT MAKING GRIP HANDLE LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23590484 ↗
• MalfunctionNov 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER EXPERIENCED INSTRUMENT BREAKAGE WHEN THE INSERTER BROKE AND THE PINS IN THE INSERTERS WERE BACKING OUT. THE LOOSE PIECE WAS IDENTIFIED BEFORE USE, AND NO PATIENT WAS INVOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT FOR THE FIRST INSERTER ALSO, THE PIN WAS BACKING OUT MAKING GRIP HANDLE LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23590138 ↗
• MalfunctionNov 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT THE SCREW THAT HOLDS HANDLE ON HAS COME OUT PARTIALLY. 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 23520328 ↗
• MalfunctionJul 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM A USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A INSERTER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE HANDLE CAME APART FROM THE INSTRUMENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22638418 ↗
• MalfunctionJul 28, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING INSERTER AND HANDLE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER DEVICE WOULD NOT LOCK, AND THE T-HANDLE RATCHETING INSTRUMENT BROKE. THE PROCEDURE WAS CONDUCTED CORRECTLY ACCORDING TO THE INSTRUCTIONS FOR USE, AND NO FRAGMENTS OF THE INSTRUMENT REMAINED IN THE PATIENT. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE INSTRUMENT BROKEN DUE TO NORMAL WEAR AND TEAR OF PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22629048 ↗
• MalfunctionJun 25, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE HANDLE OF THE INSERTER WAS NOT PROPERLY CLOSING IS OFF ALIGNMENT. THERE WAS NO PATIENT INVOLVED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22325767 ↗
• MalfunctionJun 10, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICES WOULD NOT FIT TOGETHER. THERE WAS NO PATIENT INVOLVED AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCTS WERE ALREADY USED BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22174439 ↗
• MalfunctionApr 29, 2025Difficult to Insert; Difficult to Insert

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT PRIOR TO USE, THE INSERT WOULD NOT GO INTO THE INSERTER. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCT WAS ALREADY USED BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21923890 ↗
• MalfunctionMar 3, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING AN INSERTER. IT WAS REPORTED THAT DURING STE RILE PROCESSING, AN ISSUE WAS IDENTIFIED WITH AN INSERTER WHERE THE INNER STYLET COULD NOT BE PASSED THROUGH THE INSERTER HANDLE. NO PATIENT WAS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503637 ↗
• MalfunctionDec 27, 2023Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER DID NOT HOLD THE CAGE WHILE INSERTING IT INTO THE DISC SPACE. IT TURNED PREMATURELY 3 TIMES. 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 18396014 ↗
• 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 18168180 ↗
• MalfunctionNov 10, 2023Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REPORTED INSTRUMENT. MEDICAL HISTORY OF PATIENT INCLUDES SPINAL STENOSIS. IT WAS REPORTED THAT, THE CLUTCH HANDLE WAS NOT FUNCTIONING PROPERLY.  SECOND INSERTER IN SET WAS USED, NO DELETERIOUS EFFECT ON PATIENT WAS REALIZED. PROCEDURE OR TECHNIQUE PERFORMED WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION. THERE WERE NO PATIENT SYMPTOMS REPORTED, NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18109336 ↗
• 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 17585171 ↗
• MalfunctionMay 22, 2023Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT WHEN SURGEON TRIED TO INSERT THE CAGE AND THE CAGE TURNED BEFORE HE RELEASED THE LOCK. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE THREADS ON THE CAGE ARE STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16972112 ↗
• MalfunctionAug 1, 2022Mechanical Problem; Use of Device Problem; Mechanical Problem; Use of Device Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH ARTICL THERAPY. IT WAS REPORTED THAT AT THE TIME OF INSERTION INTO THE DISC SPACE. THE CAGE HAS HORIZONTALIZED COMPRESSING THE NERVES OF THE PONYTAIL. THE PATIENT IS DEFICIENT. WHEN SURGEON TRIED TO INTRODUCE THE TRIAL, IT SUDDENLY TURNED TO COLLIDE WITH THE DURAL SAC. THIS GESTURE CAUSED 3 MICRO-BREACHES AND AN IMPACT ON THE NERVES. THIS HAS CONSEQUENCES FOR THE PATIENT, IN PARTICULAR SIGNIFICANT NEUROLOGICAL DISORDERS. NO ADDITIONAL SURGERY WAS PERFORMED OR REQUIRED.

  Patient problems: Nerve Damage; Unspecified Nervous System Problem

  MAUDE report 15137189 ↗
• 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 14545973 ↗
• InjuryMar 23, 2022Use of Device Problem; Material Deformation; Mechanics Altered; Use of Device Problem; Material Deformation; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING AN INSERTER AND CAGE USED FOR SPINAL SURGERY. PRE-OP DIAGNOSIS WAS LUMBAR HERNIA. PROCEDURE PERFORMED IN THE EVENT WAS TLIF. LEVELS IMPLANTED WAS L1/2. IT WAS REPORTED THAT INTRA-OPERATIVELY, WHEN THE ARCTIC-L WAS INSERTED, THE CAGE ROTATED AT THE INTERVERTEBRAL FORAMINA. THERE IS A POSSIBILITY THAT THE DURA INJURY OCCURRED DURING THAT TIME. AFTER THE SURGERY, THE PATIENT SUFFERED FROM PARALYSIS IN THE RIGHT LOWER LIMB. THERE WAS A DELAY OF LESS THAN 60 MINUTES. THE CAGE (8*25 MM) WAS INSTALLED ON THE REPORTED INSERTER, BUT WHEN ATTEMPTED TO INSERT INTO INTERVERTEBRAL SPACE, THE ANGLE OF THE CAGE CHANGED. THE INTERVERTEBRAL FORAMINA HAD OSTEOPETROSIS. THEREFORE, AFTER SCRAPING THE OUTER BONE, THE CAGE WAS RE-INSTALLED ON THE SAME INSERTER AND INSERTED AGAIN. BEFORE INSERTING THE CAGE, THE TRAIL WAS NOT USED/TRIED; AND A ROTATE DISTRACTOR OF 8 MM WAS IMPLEMENTED. WHEN INSTALLING THE CAGE TO THE INSERTER, IT WAS INSTALLED STRAIGHTLY ACCORDING TO THE PROCEDURE MANUAL, AND TIGHTENED THE THUMB WHEEL MORE, AND WAS PROPERLY INSTALLED. THE PARALYSIS ON THE PATIENT PREDICTED POST-OPERATIVELY, BUT

  Patient problems: Paralysis; Spinal Cord Injury

  MAUDE report 13862208 ↗