ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 56251005Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 56251005 12W 25MM 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000085445), received between Jun 1, 2020 and Jun 1, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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.
Most reported problems
Device problems
- Migration1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 1, 2020Migration; Migration
PRE OP DIAGNOSIS: INFECTION PROCEDURE PERFORMED: CAGE REMOVAL AND AUTOGENOUS BONE GRAFT WAS PERFORMED LEVELS IMPLANTED: L5/S POST OP, CAGE BACKED OUT AND PATIENT SUFFERED INFECTION. ALTHOUGH IT WAS UNKNOWN IF THE CAUSE OF INFECTION WAS CAGE BACKING OUT. AS A RESULT ADDITIONAL SURGERY WAS PERFORMED, THE CAGE WAS REMOVED AND WASHED, AND AUTOGENOUS BONE GRAFT WAS PERFORMED.
Patient problems: Unspecified Infection
MAUDE report 10104372 ↗
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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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