ARTiC-L 3D Ti Spinal System with TiONIC TechnologyRecalls & reported problems across all models
Medtronic Sofamor Danek, Inc. · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 56
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 0
We found 16 models of ARTiC-L 3D Ti Spinal System with TiONIC Technology by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 56 adverse event reports in the FDA's MAUDE database, received between Dec 17, 2018 and Sep 25, 2026 — classified as 9 injuries, 47 malfunctions.
The most frequently reported specific device problem is “Mechanics Altered” (20 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ARTiC-L 3D Ti Spinal System with TiONIC Technology problems
Device problems
- Mechanics Altered20
- Mechanical Problem14
- Use of Device Problem7
- Detachment of Device or Device Component6
- Break5
- Migration4
- Product Quality Problem3
- Material Deformation2
Patient problems
- No Clinical Signs, Symptoms or Conditions46
- No Known Impact Or Consequence To Patient4
- Pain2
- Paralysis2
- Spinal Cord Injury2
- Device Embedded In Tissue or Plaque1
- Nerve Damage1
- Unspecified Infection1
ARTiC-L 3D Ti Spinal System with TiONIC Technology models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 5330008Intervertebral fusion device with bone graft, lumbar23 reports
- ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 5330009Intervertebral fusion device with bone graft, lumbar14 reports
- ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 56250905Intervertebral fusion device with bone graft, lumbar2 reports
- ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 56300805Intervertebral fusion device with bone graft, lumbar2 reports
- ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 56300905Intervertebral fusion device with bone graft, lumbar2 reports
- ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 56251210Intervertebral fusion device with bone graft, lumbar2 reports
- ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 56300810Intervertebral fusion device with bone graft, lumbar2 reports
- ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 5330009Intervertebral fusion device with bone graft, lumbar1 report
- ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 56301310Intervertebral fusion device with bone graft, lumbar1 report
- ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 56250805Intervertebral fusion device with bone graft, lumbar1 report
- ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 56251005Intervertebral fusion device with bone graft, lumbar1 report
- ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 56251105Intervertebral fusion device with bone graft, lumbar1 report
- ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 56301005Intervertebral fusion device with bone graft, lumbar1 report
- ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 56300910Intervertebral fusion device with bone graft, lumbar1 report
- ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 56301010Intervertebral fusion device with bone graft, lumbar1 report
- ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 56350810Intervertebral fusion device with bone graft, lumbar1 report
Recent ARTiC-L 3D Ti Spinal System with TiONIC Technology adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryMar 30, 2026Device Dislodged or Dislocated
INFORMATION WAS OBTAINED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING AN IMPLANT USED FOR SPINAL THERAPY. IT WAS STATED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2026 AND CAME BACK ON (B)(6) 2026 REPORTING PAIN AFTER SURGERY. A X-RAY WAS PERFORMED THROUGH WHICH DOCTOR FOUND THE CAGE TO BE DISLOCATED. NO FURTHER COMPLICATIONS WERE REPORTED REGARDING THIS EVENT. PROCEDURE INVOLVED WAS POSTERIOR DECOMPRESSION AND INSTRUMENTED FUSION PERFORMED ON (B)(6) 2026 AT THE L4-S1 LEVEL. THE REPORTED PRODUCT WAS IMPLANTED AT THE L5-S1 LEVELS; WHICH IS WHERE THE DISLOCATION OCCURRED. REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 FOR RELOCATION.
Patient problems: Pain
MAUDE report 24726460 ↗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, 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 ↗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, 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 ↗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 ↗MalfunctionFeb 3, 2026Use of Device Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING PATIENT HAVING LEFT SIDED TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) FOR RADICULAR LEG PAIN AT L4-L5. IT WAS REPORTED THAT THE EXPIRED CAGE WAS IMPLANTED. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE SURGEON IS UNAWARE THAT THE CAGE WAS EXPIRED AND THERE IS NO PLAN OF REVISION SURGERY FOR THE REMOVAL OF EXPIRED CAGE. THE PATIENT HAS NOT REPORTED ANY ADVERSE EFFECTS AND IS RECOVERING AS PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24243378 ↗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 ↗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 ↗
Other Medtronic Sofamor Danek, Inc. products
- CD HORIZON Spinal System342 models · 2,323 reports
- GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM)25 models · 12 reports · 14 recalls
- METRx System5 models · 672 reports
- INFUSE Bone Graft6 models · 576 reports · 1 recall
- CD HORIZON SOLERA VOYAGER Spinal System60 models · 411 reports
- POWEREASE Instruments8 models · 331 reports · 1 recall
- Catalyft PL Expandable Interbody System16 models · 279 reports · 1 recall
- INFINITY Occipitocervical Upper Thoracic System35 models · 63 reports · 5 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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