Axium™ MN13650Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067025616), received between May 5, 2023 and May 5, 2023 — 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

Recent adverse event reports

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

• InjuryMay 5, 2023Material Fragmentation; Use of Device Problem; Material Fragmentation; Use of Device Problem

  IT WAS REPORTED THAT DURING A DRG TRIAL PROCEDURE ON (B)(6) 2023 THERE WAS A COMPLICATION WITH THE DRG BIG CURVE SHEATH. THE PHYSICIAN WAS TRYING TO ADVANCE THE SHEATH TOWARDS THE TARGET LOCATION AT THE RIGHT L5 DRG WHEN HE WAS HAVING TROUBLE DIRECTING IT. HE REMOVED THE SHEATH AND GUIDE WIRE FROM THE EPIDURAL NEEDLE, AND WHEN HE DID THE DISTAL END OF THE BIG CURVE SHEATH BROKE OFF AND REMAINED IN THE PATIENT. WHEN THE SHEATH WAS REMOVED IT WAS CLEARLY VISIBLE THAT A PART OF IT WAS MISSING. THIS WAS ALSO CONFIRMED WITH X-RAY IMAGING SHOWING THE RADIOPAQUE DISTAL TIP OF THE SHEATH. IT WAS ALSO CONFIRMED WITH LATERAL X-RAY IMAGING THAT THIS PIECE WAS NOT IN THE EPIDURAL SPACE. IT WAS POSTERIOR TO THE LAMINA AT THAT SPINE LEVEL. THE TRIAL PHYSICIAN DID NOT HAVE THE MEANS TO RETRIEVE IT, AND IT WAS ABANDONED INSIDE THE PATIENT. THE PROCEDURE WAS STILL COMPLETED AS PLANNED, AND THE PATIENT DID NOT APPEAR TO HAVE ANY FURTHER COMPLICATIONS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16880819 ↗