ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 56300810Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 56300810 12W 30MM X 8MM 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 00763000085742), received between Dec 17, 2018 and Mar 13, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Handling Problem” (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 Handling Problem1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Migration1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2025Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem
INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING AN IMPLANT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE WRONG SIZE IMPLANT WAS ACCIDENTLY OPENED. THERE WAS NO PATIENT INVOLVED AT THE TIME OF EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21591888 ↗InjuryDec 17, 2018Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration
IT WAS REPORTED THAT TWO MONTHS POST-OP, THE IMPLANT BECAME LOOSE FROM ITS POSITION AND WAS BEING EXPELLED POSTERIORLY. HENCE, ON (B)(6) 2018, A REVISION SURGERY WAS PERFORMED, DURING WHICH THE IMPLANT WAS REMOVED COMPLETELY.
Patient problems: No Known Impact Or Consequence To Patient; Pain
MAUDE report 8170946 ↗
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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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