Axle Interspinous Fusion System X060-0318Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M697X06003181), received between Sep 4, 2018 and Jun 20, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2019Break; Fracture; Break; Fracture

  THE COMPLAINANT REPORTED THAT WHEN THE SURGEON PRESSED THE GRIP-LOCK INSERTER TO SECURE THE IMPLANT, THE INSERTER SUDDENLY BROKE. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8719641 ↗
• MalfunctionSep 14, 2018Break; Break

  THE COMPLAINANT REPORTED THAT A CROSS BAR PLATE GRIP-LOCK INSERTER BROKE. THE COMPLAINANT CONFIRMED THAT THERE WERE NO PATIENT COMPLICATIONS ASSOCIATED WITH THE INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7877290 ↗
• MalfunctionSep 4, 2018Break; Break

  THE COMPLAINANT REPORTED THAT WHEN THE INSERTER AND IMPLANT WAS BEING MANIPULATED FOR PLACEMENT, ONE OF THE HANDLES OF THE INSERTER BROKE FROM THE BODY OF THE INSTRUMENT. THE IMPLANT HAD ALREADY BEEN PLACED THROUGH THE OPENING PREPARED IN THE INTERSPINOUS SPACE WHEN THE MALFUNCTION OCCURRED. NO FURTHER PLACEMENT OR MANIPULATION WAS REQUIRED. THERE WERE NO KNOWN PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7843688 ↗