Axle Interspinous Fusion System X060-0370Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M697X06003701), received between May 9, 2019 and Jan 29, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2025Fracture; Fracture

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 01/08/2025. IT WAS REPORTED THAT A DISTAL COMPRESSING ARM OF A SYSTEM COMPRESSOR MALFUNCTIONED WHILE BEING USED DURING A SURGICAL PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT, HOWEVER THE MALFUNCTION RESULTED IN A SLIGHT DELAY IN THE PROCEDURE. AN ALTERNATE AVAILABLE INSTRUMENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264185 ↗
• MalfunctionDec 7, 2023Break; Break

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON (B)(6) 2023. IT WAS REPORTED THAT A DISTAL COMPRESSING ARM OF A SYSTEM COMPRESSOR MALFUNCTIONED WHILE BEING USED DURING A SURGICAL PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. AN ALTERNATE AVAILABLE INSTRUMENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A RETURN AUTHORIZATION WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH AS OF 12/07/2023 HAS NOT BEEN RECEIVED AT THE MANUFACTURER FOR COMPLAINT ASSESSMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18286706 ↗
• MalfunctionMar 29, 2023Material Fragmentation; Material Fragmentation

  THE MANUFACTURER WAS MADE AWARE OF AN INSTRUMENT MALFUNCTION ON (B)(6) 2023. IT WAS REPORTED THAT A SMALL PORTION OF THE FEMALE SPRING OF A SYSTEM COMPRESSOR BROKE OFF WHILE BEING USED DURING A SURGICAL PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT. THE COMPLAINT COMPRESSOR WAS ABLE TO BE USED TO SUCCESSFULLY COMPLETE THE SURGICAL PROCEDURE. AN RMA# WAS ISSUED FOR RETURN OF THE COMPLAINT COMPRESSOR, WHICH AS OF (B)(6) 2023 HAS NOT BEEN RECEIVED AT THE MANUFACTURER FOR ASSESSMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16637030 ↗
• MalfunctionMay 9, 2019Material Separation; Material Separation

  THE COMPLAINANT REPORTED THAT THE COMPRESSOR WAS DAMAGED WHILE PERFORMING IMPLANT COMPRESSION DURING SURGERY. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8597833 ↗