ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 56300910Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 56300910 12W 30MM X 9MM 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000085759), received between Jun 17, 2020 and Jun 17, 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
- 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 17, 2020Migration; Migration
PRE OP DIAGNOSIS: LUMBAR SPINAL CANAL STENOSIS PROCEDURE PERFORMED: CAGE REPLACEMENT SCREW REPLACEMENT LEVELS IMPLANTED: L5/S POST-OP, CAGE BACK-OUT. IN POSTOPERATIVE IMAGE DIAGNOSIS ONE MONTH AFTER DISCHARGE, IT WAS FOUND THAT THE CAGE WAS BACKING OUT TO VICINITY OF THE POSTERIOR WALL, SO CAGE REPLACEMENT WAS PERFORMED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10161902 ↗
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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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