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Axium™ MN14000Recalls & reported problems

Spinal Modulation, Inc. · Curved Needle · Class 3

Data updated Oct 16, 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 05415067025708), received between Sep 1, 2022 and Sep 1, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (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 16, 2026.

Most reported problems

Device problems

  • Material Fragmentation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • InjurySep 1, 2022Material Fragmentation; Material Fragmentation

    IT WAS REPORTED THAT DURING THE PATIENT'S LEAD REPLACEMENT PROCEDURE A FOREIGN OBJECT WAS DISCOVERED INSIDE THE PATIENT. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY RETRIEVE THE FOREIGN OBJECT AND EXPLANT IT AND THE PROCEDURE WAS COMPLETED. STIMULATION WAS REPORTEDLY RESTORED POSTOPERATIVELY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15342090 ↗

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Sources and updates

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