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ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology 5330009 (UDI 00643169762077)Recalls & reported problems

Medtronic Sofamor Danek, Inc. · INSERTER 5330009 ARTICULATING INR SHAFT · Class 2

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 00643169762077), received between Mar 23, 2022 and Mar 23, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Material Deformation” (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

  • Material Deformation1
  • Mechanics Altered1
  • Use of Device Problem1

Patient problems

  • Paralysis1
  • Spinal Cord Injury1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 23, 2022Use of Device Problem; Material Deformation; Mechanics Altered; Use of Device Problem; Material Deformation; Mechanics Altered

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING AN INSERTER AND CAGE USED FOR SPINAL SURGERY. PRE-OP DIAGNOSIS WAS LUMBAR HERNIA. PROCEDURE PERFORMED IN THE EVENT WAS TLIF. LEVELS IMPLANTED WAS L1/2. IT WAS REPORTED THAT INTRA-OPERATIVELY, WHEN THE ARCTIC-L WAS INSERTED, THE CAGE ROTATED AT THE INTERVERTEBRAL FORAMINA. THERE IS A POSSIBILITY THAT THE DURA INJURY OCCURRED DURING THAT TIME. AFTER THE SURGERY, THE PATIENT SUFFERED FROM PARALYSIS IN THE RIGHT LOWER LIMB. THERE WAS A DELAY OF LESS THAN 60 MINUTES. THE CAGE (8*25 MM) WAS INSTALLED ON THE REPORTED INSERTER, BUT WHEN ATTEMPTED TO INSERT INTO INTERVERTEBRAL SPACE, THE ANGLE OF THE CAGE CHANGED. THE INTERVERTEBRAL FORAMINA HAD OSTEOPETROSIS. THEREFORE, AFTER SCRAPING THE OUTER BONE, THE CAGE WAS RE-INSTALLED ON THE SAME INSERTER AND INSERTED AGAIN. BEFORE INSERTING THE CAGE, THE TRAIL WAS NOT USED/TRIED; AND A ROTATE DISTRACTOR OF 8 MM WAS IMPLEMENTED. WHEN INSTALLING THE CAGE TO THE INSERTER, IT WAS INSTALLED STRAIGHTLY ACCORDING TO THE PROCEDURE MANUAL, AND TIGHTENED THE THUMB WHEEL MORE, AND WAS PROPERLY INSTALLED. THE PARALYSIS ON THE PATIENT PREDICTED POST-OPERATIVELY, BUT

    Patient problems: Paralysis; Spinal Cord Injury

    MAUDE report 13862242 ↗

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Sources and updates

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