ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 56251210Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 56251210 12W 25MM X 12MM 10 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000085704), received between Sep 23, 2024 and Mar 30, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionSep 23, 2024Mechanical Problem; Mechanical Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT THE HINGE WAS FAULTY AS CAGE WAS ROTATING BEFORE INSERTER WAS UNLOCKED, CAUSING THE CAGE TO BE IMPLANTED IN THE WRONG POSITION. ONCE A NEW CAGE WAS OPENED THERE WAS NO ISSUES. 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 20276575 ↗
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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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