ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 56251105Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 56251105 12W 25MM X 11MM 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 00763000085452), received between Jun 19, 2020 and Jun 19, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
- Migration or Expulsion of Device1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 19, 2020Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT THE PATIENT UNDERWENT OPEN SURGERY AT L4/5/S DUE TO LCS (LUMBAR CANAL STENOSIS) AND ADJACENT SEGMENT DISEASE. POST-OP, CAGE BACKED OUT. HENCE ON AN (B)(6) 2020, A REVISION SURGERY WAS PERFORMED IN WHICH REMOVAL OF CAGE IMPLANTED AT L5/S DONE. THE CROSSLINK AND ROD WERE REMOVED. REMOVING CAGE AT L5/S WAS PERFORMED FROM THE LEFT SIDE SUCCESSFULLY WITH SPECIFIC INSTRUMENT FOR REMOVAL. FOR L5/S, THE BONE FROM THE ILIAC BONE WAS TRANSPLANTED INTO THE INTERVERTEBRAL DISC SPACE. THE ROD AND CROSSLINK WAS INSERTED AND WOUND CLOSURE WAS PERFORMED. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME AND NO OTHER PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10173078 ↗
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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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