ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 56301010Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 56301010 12W 30MM X 10MM 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
- 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 00763000085766), received between Sep 24, 2024 and Sep 24, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanics Altered” (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
- Mechanics Altered1
- Product Quality 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.
MalfunctionSep 24, 2024Product Quality Problem; Mechanics Altered; Product Quality Problem; Mechanics Altered
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, IMPLANT WOULD ARTICULATE WHILE ATTACHED TO THE INSERTER EVEN THOUGH IMPLANT WAS CORRECTLY THREADED ON AND HANDLE WAS IN CLOSED (LOCKED POSITION). PROCEDURE OR TECHNIQUE PERFORMED WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). A NEW IMPLANT WAS OPENED AND THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20290356 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
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- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
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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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