ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology 53401225Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 53401225 40MM X 12MM 25 DEGREE TI · Class 2 · Implant
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 00643169800502), received between Dec 31, 2025 and Feb 15, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
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.
MalfunctionFeb 15, 2026Break
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (USER FACILITY, REGULATORY BODY) REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE CAGE WAS BROKEN DURING IMPLANTATION. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTH ER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24341432 ↗MalfunctionDec 31, 2025Break; Break
ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE STATING THAT UNFORTUNATELY ONE OF THE HOSPITAL EMPLOYEES WORKING IN DECON THREW AWAY THIS BROKEN IMPLANT BECAUSE SHE WAS UNABLE TO CLEAN IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23931841 ↗
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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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