Axle Interspinous Fusion System X060-1520Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI M697X06015201), received between Oct 26, 2018 and Apr 23, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (11 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2025Break; Break

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 03/25/2025. A SYSTEM INSERTER/COMPRESSOR WAS RETURNED TO THE MANUFACTURER COUPLED WITH ANOTHER SYSTEM INSERTER COMPLAINT. UPON RECEIPT OF THIS INSERTER, IT WAS NOTED THAT THE STOP OF THE DISTAL TIP WAS DAMAGED. COMMUNICATIONS WITH THE COMPLAINANT CONFIRMED THIS INSTRUMENT WAS POSSIBLY UTILIZED DURING PROCEDURE, HOWEVER, THE COMPLAINANT WAS UNAWARE OF DAMAGE AT THE DISTAL TIP. IT IS UNCLEAR AS TO WHEN THE DAMAGE TO THE DISTAL TIP OCCURRED. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892815 ↗
• MalfunctionApr 23, 2025Break; Break

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 03/25/2025. IT WAS REPORTED THAT A SYSTEM INSERTER WAS STRUCK WITH A MALLET DURING PROCEDURE, RESULTING IN THE PROXIMAL RATCHETING ARM TO BREAK OFF. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT. THE PHYSICIAN WAS ABLE TO USE AN ALTERNATE INSTRUMENT TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE INSTRUMENT WAS RETURNED TO THE MANUFACTURER AND UPON VISUAL ASSESSMENT, ADDITIONAL DAMAGE WAS IDENTIFIED AT THE DISTAL TIP OF THE SYSTEM INSERTER/COMPRESSOR. THE COMPLAINANT WAS UNAWARE OF THE ADDITIONAL DAMAGE IDENTIFIED AT THE DISTAL TIP OF THE SYSTEM INSERTER/COMPRESSOR. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892480 ↗
• MalfunctionFeb 20, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 1/22/2025. IT WAS REPORTED THAT AFTER PLACING A SYSTEM IMPLANT, THE INSERTER/COMPRESSOR UTILIZED WAS STUCK ON THE IMPLANT AND SUBSEQUENTLY REMOVED FROM THE WOUND SPACE. THE IMPLANT WAS REPOSITIONED AND SUCCESSFULLY IMPLANTED WITH A MINOR DELAY IN TREATMENT. THE REPORTED PRODUCT COMPLAINT DID NOT SPEAK TO A DEFICIENT INSTRUMENT, BUT RATHER STATED THAT THE SYSTEM INSERTER/COMPRESSOR, "...HAS TO BE MANIPULATED AROUND THE CROSS BAR AND IT BECOMES VERY DIFFICULT WITH THE LITTLE SPACE THAT PHYSICIAN HAS TO REMOVE THE INSERTER." THERE WAS NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THE COMPLAINT INSTRUMENT WAS NOT RETURNED TO THE MANUFACTURER FOR ASSESSMENT, THE COMPLAINANT MAINTAINED POSSESSION OF THE INSTRUMENT FOR FUTURE PROCEDURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21426865 ↗
• MalfunctionSep 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INTERSPINOUS FUSION SURGERY. DURING THE PROCEDURE, IT WAS REPORTED THAT THE FEET AT THE TIP OF THE INSERTER/COMPRESSOR BROKE OFF AND INTO THE PATIENT. IT WAS NOTICED ON X-RAY AND THE PIECES WERE RETRIEVED FROM THE PATIENT WITHOUT INCIDENT. THE COMPLAINANT STATED THAT, "THE IMPLANT WAS SECURED AND IN PLACE, SO THE PROCEDURE WAS COMPLETED." THERE WERE NO PATIENT COMPLICATIONS OR DELAY IN TREATMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20323072 ↗
• MalfunctionAug 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SPINOUS PROCESS FIXATION PROCEDURE AT AN UNKNOWN LEVEL. DURING THE PROCEDURE, WHILE TIGHTENING THE SET SCREW THAT LOCKS THE CROSS-BAR PLATE TO THE INSERTER, THE DISTAL LIP OF ONE OF THE INSERTER ARMS BROKE OFF. AN ALTERNATE INSTRUMENT WAS USED TO FINISH THE PROCEDURE THAT RESULTED IN A TWENTY (20) MINUTE DELAY. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19931733 ↗
• MalfunctionMay 20, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DISTAL IMPLANT GRASPING PORTION OF A SYSTEM INSERTER/COMPRESSOR WAS BROKEN WHILE ENGAGING A SYSTEM IMPLANT. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT. ALTERNATE AVAILABLE INSTRUMENTATION WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A RETURN AUTHORIZATION NUMBER WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON 5/01/2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354996 ↗
• MalfunctionMay 20, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DISTAL IMPLANT GRASPING PORTION OF A SYSTEM INSERTER/COMPRESSOR WAS BROKEN WHILE ENGAGING A SYSTEM IMPLANT. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT. A RETURN AUTHORIZATION NUMBER WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER FOR ASSESSMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354731 ↗
• MalfunctionMar 25, 2024Break; Break

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 3/01/2024. IT WAS REPORTED THAT A SYSTEM INSERTER/COMPRESSOR WAS BROKEN DURING A SURGICAL PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT. THE SYSTEM IMPLANT WAS SUCCESSFULLY PLACED WITH THE COMPLAINT INSERTER/COMPRESSOR. AN RMA# WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON 3/07/2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18969083 ↗
• MalfunctionJun 2, 2023Material Fragmentation; Material Fragmentation

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 5/04/2023. IT WAS REPORTED THAT A SYSTEM INSERTER/COMPRESSOR WAS BROKEN WHEN THE INCORRECT SET SCREW OF THE INSTRUMENT WAS ROTATED FOR FINAL TIGHTENING OF A SYSTEM IMPLANT. THE COMPLAINANT REPORTED THAT A SYSTEM SCREWDRIVER WAS ALSO BROKEN DURING THE INSERTER/COMPRESSOR MALFUNCTION. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT. AN ALTERNATE AVAILABLE INSERTER/COMPRESSOR AND SCREWDRIVER WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. AN RMA# WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENTS, WHICH WERE RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON 5/17/2023. THIS REPORT IS ASSOCIATED WITH MDR# 3005031160-2023-00009.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17050195 ↗
• MalfunctionJan 19, 2023Material Fragmentation; Material Fragmentation

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 12/20/2022. IT WAS REPORTED THAT THE DISTAL TIP OF A SYSTEM INSERTER/COMPRESSOR FRACTURED DURING A SURGICAL PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT, ALTHOUGH THERE WAS A DELAY IN TREATMENT TO ADDRESS THE INSTRUMENT MALFUNCTION AND UTILIZE AN ALTERNATE AVAILABLE INSTRUMENT. A RETURN AUTHORIZATION WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON 12/27/2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16210520 ↗
• MalfunctionDec 2, 2022Material Fragmentation; Material Fragmentation

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON (B)(6) 2022. IT WAS REPORTED THAT A HANDLE SPRING OF A SYSTEM INSERTER/COMPRESSOR WAS IDENTIFIED AS BROKEN AFTER BEING SUCCESSFULLY USED TO PLACE AND COMPRESS SYSTEM IMPLANTS. THE INSTRUMENT DEFICIENCY WAS IDENTIFIED AFTER THE PROCEDURE WAS COMPLETED AND THE SCRUB TECH CLOSED THE LATCH OF THE INSERTER AND THE HANDLE SPRING BROKE. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT. A RETURN AUTHORIZATION NUMBER WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER ON 11/10/2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15910549 ↗
• MalfunctionNov 9, 2022Material Fragmentation; Material Fragmentation

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 10/14/2022. IT WAS REPORTED THAT A HANDLE SPRING OF A SYSTEM INSERTER/COMPRESSOR MALFUNCTIONED DURING A SURGICAL PROCEDURE ON (B)(6) 2022 AFTER FINAL LOCKING A SYSTEM IMPLANT CONSTRUCT. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT. A RETURN AUTHORIZATION NUMBER WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER ON 10/17/2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15764560 ↗
• MalfunctionAug 10, 2022Material Fragmentation; Material Fragmentation

  THE MANUFACTURER WAS MADE AWARE OF A SYSTEM INSERTER MALFUNCTION ON (B)(6) 2022. IT WAS REPORTED THAT THE DISTAL TIP OF ONE OF THE INSTRUMENT ARMS FRACTURED DURING A SURGICAL PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. ALTERNATE AVAILABLE INSTRUMENTS WERE USED TO SUCCESSFULLY PLACE AND COMPRESS THE IMPLANT CONSTRUCT, WITH REPORTED GOOD PLACEMENT. A REPLACEMENT INSTRUMENT WAS PROVIDED TO THE COMPLAINANT AND A RETURN AUTHORIZATION WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER ON 7/26/2022 FOR COMPLAINT ASSESSMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15203086 ↗
• MalfunctionJul 18, 2022Material Fragmentation; Material Fragmentation

  THE MANUFACTURER RECEIVED NOTIFICATION ON 6/21/2022 OF A SYSTEM INSERTER/COMPRESSOR THAT MALFUNCTIONED DURING A SURGICAL PROCEDURE. IT WAS REPORTED THAT ONE OF THE DISTAL TIPS OF THE INSTRUMENT FRACTURED WHILE COMPRESSING INTERSPINOUS PLATES INTO PLACE AND SECURING THE PLATES. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ALTERNATE AVAILABLE INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15048096 ↗
• MalfunctionApr 6, 2022Material Fragmentation; Material Fragmentation

  THE MANUFACTURER RECEIVED NOTIFICATION ON 3/08/2022 OF A SYSTEM INSERTER/COMPRESSOR THAT MALFUNCTIONED DURING A SURGICAL PROCEDURE. IT WAS REPORTED THAT ONE OF THE DISTAL TIPS OF THE INSTRUMENT FRACTURED WHILE COMPRESSING INTERSPINOUS PLATES INTO PLACE AND SECURING THE PLATES. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ALTERNATE AVAILABLE INSTRUMENT. THE COMPLAINT INSTRUMENT ARRIVED AT THE MANUFACTURER FOR ASSESSMENT ON 3/10/2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14029759 ↗
• MalfunctionOct 6, 2021Material Fragmentation; Material Fragmentation

  THE COMPANY RECEIVED NOTIFICATION ON (B)(6) 2021 OF A SYSTEM INSERTER/COMPRESSOR THAT MALFUNCTIONED DURING A SURGICAL PROCEDURE. IT WAS REPORTED THAT ONE OF THE DISTAL TIPS OF THE INSTRUMENT FRACTURED WHILE COMPRESSING INTERSPINOUS PLATES AFTER BEING PLACED. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. ALTERNATE AVAILABLE INSTRUMENTS WERE USED TO SUCCESSFULLY COMPLETE THE SURGICAL PROCEDURE. THE COMPLAINT INSTRUMENT ARRIVED AT THE MANUFACTURER FOR ASSESSMENT ON 9/28/2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12586780 ↗
• MalfunctionSep 21, 2021Material Fragmentation; Material Fragmentation

  THE COMPANY RECEIVED NOTIFICATION ON (B)(6) 2021 OF A SYSTEM INSERTER/COMPRESSOR THAT WAS REPORTED TO MALFUNCTION WHEN LOADING AN IMPLANT ONTO THE INSTRUMENT. FIVE ATTEMPTS TO GATHER RELEVANT COMPLAINT INCIDENT INFORMATION AND REQUEST THE INSTRUMENT TO BE RETURNED WERE MADE, AND NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED AS PART OF THIS INSTRUMENT COMPLAINT. THE INSTRUMENT HAS NOT BEEN RECEIVED AT THE MANUFACTURER FOR COMPLAINT ASSESSMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12510841 ↗
• MalfunctionJul 17, 2020Fracture; Fracture

  THE COMPANY RECEIVED NOTIFICATION ON (B)(6) 2020 THAT A SURGICAL INSTRUMENT HAD A MALFUNCTION DURING A SURGICAL PROCEDURE. IT WAS REPORTED THAT THE DISTAL END OF A SYSTEM INSERTER/COMPRESSOR FRACTURED WHEN BEING USED TO COMPRESS IMPLANT PLATES. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THERE WAS AN ALTERNATE INSTRUMENT AVAILABLE, WHICH WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10289073 ↗
• MalfunctionOct 26, 2018Fracture; Fracture

  THE COMPLAINANT REPORTED THAT AN AXLE ALL IN ONE INSERTER BROKE DURING INSERTION OF AN IMPLANT. A SECOND INSERTER WAS AVAILABLE, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO KNOWN PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8010522 ↗