Axle Interspinous Fusion System C060-0010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M697C06000101), received between Jul 15, 2024 and Jul 15, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL POSTERIOR LUMBER INTERSPINOUS PROCESS FUSION PROCEDURE AT AN UNKNOWN LEVEL. DURING THE PROCEDURE, WHILE TIGHTENING THE RETENTION SCREW OF THE ALL-IN-ONE (AIO) INSERTER TO ENGAGE THE SYSTEM IMPLANT, THE DISTAL IMPLANT GRASPING PORTION ON THE LOCKING PLATE SIDE OF THE INSTRUMENT FRACTURED. A SECOND INSERTER WAS USED TO PROCEED TO FORWARD WITH THE PROCEDURE. SUBSEQUENTLY, DURING COMPRESSION OF THE IMPLANT ONTO THE SPINOUS PROCESSES, THE DISTAL FUNCTIONAL FEATURE OF THE CROSS BAR PLATE SIDE OF THE SECOND INSTRUMENT FRACTURED OFF. A THIRD INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER ISSUES. IT WAS ALSO REPORTED THAT THE DISTAL TIP OF THE SCREWDRIVER, USED TO TIGHTEN THE RETENTION SCREW OF THE INSERTER FRACTURED OFF DURING THE CASE; HOWEVER, IT IS UNKNOWN IF THIS OCCURRED DURING THE USE OF THE FIRST OR SECOND INSERTER DEVICE. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT. NO ADDITIONAL INFORMATION IS AVAILABLE. REPORT 2 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19744265 ↗
• MalfunctionJul 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL POSTERIOR LUMBER INTERSPINOUS PROCESS FUSION PROCEDURE AT AN UNKNOWN LEVEL. DURING THE PROCEDURE, WHILE TIGHTENING THE RETENTION SCREW OF THE ALL-IN-ONE (AIO) INSERTER TO ENGAGE THE SYSTEM IMPLANT, THE DISTAL IMPLANT GRASPING PORTION ON THE LOCKING PLATE SIDE OF THE INSTRUMENT FRACTURED. A SECOND INSERTER WAS USED TO PROCEED TO FORWARD WITH THE PROCEDURE. SUBSEQUENTLY, DURING COMPRESSION OF THE IMPLANT ONTO THE SPINOUS PROCESSES, THE DISTAL FUNCTIONAL FEATURE OF THE CROSS BAR PLATE SIDE OF THE SECOND INSTRUMENT FRACTURED OFF. A THIRD INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER ISSUES. IT WAS ALSO REPORTED THAT THE DISTAL TIP OF THE SCREWDRIVER, USED TO TIGHTEN THE RETENTION SCREW OF THE INSERTER FRACTURED OFF DURING THE CASE; HOWEVER, IT IS UNKNOWN IF THIS OCCURRED DURING THE USE OF THE FIRST OR SECOND INSERTER DEVICE. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT. NO ADDITIONAL INFORMATION IS AVAILABLE. REPORT 1 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19744250 ↗