Axle Interspinous Fusion System X060-0080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M697X06000801), received between Oct 20, 2021 and Oct 20, 2021 — classified as 1 malfunction.

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 18, 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.

• MalfunctionOct 20, 2021Material Fragmentation; Material Fragmentation

  THE COMPANY WAS NOTIFIED ON 9/28/2021 OF AN IMPLANT MALFUNCTION THAT OCCURRED AFTER PLACING AN INTERSPINOUS PLATE CONSTRUCT. AFTER IMPLANT PLACEMENT, THE PHYSICIAN ELECTED TO MAKE A POSITION ADJUSTMENT OF THE IMPLANTS. WHEN THE SET SCREW OF A LOCKING PLATE ASSEMBLY WAS BEING LOOSENED, IT SHEARED OFF. THE IMPLANT CONSTRUCT WAS REMOVED AND SUCCESSFULLY REPLACED WITH ALTERNATE IMPLANTS WITHOUT ANY FURTHER ISSUES. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THE COMPLAINT DEVICE ARRIVED AT THE MANUFACTURER FOR ASSESSMENT ON 10/01/2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12668531 ↗