ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 56301005Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 56301005 12W 30MM X 10MM 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000085520), received between Jul 22, 2024 and Jul 22, 2024 — classified as 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.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2024Mechanical Problem; Mechanical Problem
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH TLIF PROCEDURE AT L3/4. IT WAS REPORTED THAT THE CAGE WOULD NOT THREAD ONTO THE INSERTER. THE PATIENT HAD NO COMPLICATIONS, AS THE IMPLANT WAS NOT IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19789984 ↗
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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.
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