ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 56300805Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 56300805 12W 30MM X 8MM 5 DG TI · Class 2 · Implant
All models of ARTiC-L 3D Ti Spinal System with TiONIC Technology (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000085506), received between Jan 1, 2025 and Jan 2, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Mechanics Altered” (2 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.
Reports received per month
Most reported problems
Device problems
- Mechanics Altered2
- Product Quality Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 2, 2025Product Quality Problem; Mechanics Altered; Product Quality Problem; Mechanics Altered
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF FOR AN IND ICATION OF LUMBAR STENOSIS. IT WAS REPORTED THAT WHEN ATTACHING THE ARTIC TO THE INSERTER, THE TIP OF THE INSERTER COULD ONLY BE INSERTED ABOUT HALF WAY AND COULD NOT BE PROPERLY ATTACHED. THE SAME SIZE WAS OPENED IN ANOTHER ONE, BUT IT COULD NOT BE ATTACHED FOR THE SAME REASON. THE PRODUCT DID NOT COME IN CONTACT WITH THE PATIENT. 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 21055476 ↗MalfunctionJan 1, 2025Product Quality Problem; Mechanics Altered; Product Quality Problem; Mechanics Altered
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF FOR AN INDICATION OF LUMBAR STENOSIS. IT WAS REPORTED THAT WHEN ATTACHING THE ARTIC TO THE INSERTER, THE TIP OF THE INSERTER COULD ONLY BE INSERTED ABOUT HALFWAY AND COULD NOT BE PROPERLY ATTACHED. THE SAME SIZE WAS OPENED IN ANOTHER ONE, BUT IT COULD NOT BE ATTACHED FOR THE SAME REASON. THE PRODUCT DID NOT COME IN CONTACT WITH THE PATIENT. 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 21051159 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
- T-PAL 03.812.003Synthes GmbH · Intervertebral fusion device with bone graft, lumbar152 reports
- T-PAL 03.812.004Synthes GmbH · Intervertebral fusion device with bone graft, lumbar120 reports
- Catalyft PL Expandable Interbody System 6068073Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall66 reports
- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
- Catalyft PL Expandable Interbody System 6068076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall46 reports
- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
- Catalyft PL Expandable Interbody System 6069096Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall25 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page