Axle Interspinous Fusion System X060-0320Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI M697X06003201), received between Apr 12, 2018 and Jul 15, 2024 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (14 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 25 most recent of 25 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 3 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19744288 ↗
• MalfunctionAug 7, 2023Material Fragmentation; Material Fragmentation

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON (B)(6) 2023. IT WAS REPORTED THAT THE DISTAL TIP OF A SYSTEM SCREWDRIVER FRACTURED WHEN IT WAS ROTATED TO FINAL TIGHTEN THE SET SCREW OF A SYSTEM IMPLANT. THE SURGEON ELECTED TO USE AN ALTERNATE DEVICE FROM A DIFFERENT MANUFACTURER TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. AN RMA# WAS ISSUED FOR RETURN OF THE COMPLAINT SCREWDRIVER, WHICH ARRIVED AT THE MANUFACTURER FOR ASSESSMENT ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17476191 ↗
• 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# 3005031160-2023-00008.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17050196 ↗
• MalfunctionMar 9, 2023Material Fragmentation; Material Fragmentation

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 2/09/2023. IT WAS REPORTED THAT THE DISTAL TIP OF A SYSTEM SCREWDRIVER FRACTURED FROM THE INSTRUMENT WHILE BEING USED IN A SURGICAL PROCEDURE. A RETURN AUTHORIZATION ISSUED FOR RETURN OF THE SYSTEM SCREWDRIVER AND TORQUE-LIMITING HANDLE THAT WAS BEING USED WHEN THE MALFUNCTION OCCURRED, WHICH WAS RECEIVED AT THE MANUFACTURER ON 3/07/2023 FOR ASSESSMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16517654 ↗
• MalfunctionJan 11, 2023Material Fragmentation; Material Fragmentation

  THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON (B)(6) 2022. IT WAS REPORTED THAT THE DISTAL TIP OF A SYSTEM SCREWDRIVER FRACTURED WHILE FINAL TIGHTENING SYSTEM IMPLANT PLATES. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT, THE FRACTURED PORTION OF THE SCREWDRIVER WAS REMOVED FROM THE SURGICAL SITE AND THE SURGEON CONFIRMED THE IMPLANT CONSTRUCT WAS LOCKED AND STABLE. A RETURN AUTHORIZATION WAS ISSUED FOR RETURN OF THE SURGICAL TRAY THAT CONTAINED THE COMPLAINT SCREWDRIVER, WHICH WAS RECEIVED AT THE MANUFACTURER FOR ASSESSMENT ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16141980 ↗
• MalfunctionOct 27, 2022Material Fragmentation; Material Fragmentation

  THE MANUFACTURER RECEIVED NOTIFICATION ON (B)(6) 2022 OF TWO SYSTEM SCREWDRIVERS THAT MALFUNCTIONED DURING A SURGICAL PROCEDURE. REPLACEMENT INSTRUMENTS WERE PROVIDED TO THE COMPLAINANT, AND A RETURN AUTHORIZATION WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENTS. ON (B)(6) 2022 TWO SYSTEM TRAYS CONTAINING A TOTAL OF THREE SCREWDRIVERS WITH MALFUNCTIONED DISTAL TIPS WERE RECEIVED AT THE MANUFACTURER FOR COMPLAINT ASSESSMENT. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. REPEATED ATTEMPTS TO COLLECT RELEVANT COMPLAINT INCIDENT INFORMATION WERE MADE, WITH MINIMAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15685849 ↗
• MalfunctionOct 27, 2022Material Fragmentation; Material Fragmentation

  THE MANUFACTURER RECEIVED NOTIFICATION ON (B)(6) 2022 OF TWO SYSTEM SCREWDRIVERS THAT MALFUNCTIONED DURING A SURGICAL PROCEDURE. REPLACEMENT INSTRUMENTS WERE PROVIDED TO THE COMPLAINANT, AND A RETURN AUTHORIZATION WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENTS. ON (B)(6) 2022 TWO SYSTEM TRAYS CONTAINING A TOTAL OF THREE SCREWDRIVERS WITH MALFUNCTIONED DISTAL TIPS WERE RECEIVED AT THE MANUFACTURER FOR COMPLAINT ASSESSMENT. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. REPEATED ATTEMPTS TO COLLECT RELEVANT COMPLAINT INCIDENT INFORMATION WERE MADE, WITH MINIMAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15685742 ↗
• MalfunctionOct 27, 2022Material Fragmentation; Material Fragmentation

  THE MANUFACTURER RECEIVED NOTIFICATION ON 9/27/2022 OF TWO SYSTEM SCREWDRIVERS THAT MALFUNCTIONED DURING A SURGICAL PROCEDURE. REPLACEMENT INSTRUMENTS WERE PROVIDED TO THE COMPLAINANT, AND A RETURN AUTHORIZATION WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENTS. ON 10/04/2022 TWO SYSTEM TRAYS CONTAINING A TOTAL OF THREE SCREWDRIVERS WITH MALFUNCTIONED DISTAL TIPS WERE RECEIVED AT THE MANUFACTURER FOR COMPLAINT ASSESSMENT. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. REPEATED ATTEMPTS TO COLLECT RELEVANT COMPLAINT INCIDENT INFORMATION WERE MADE, WITH MINIMAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15685705 ↗
• MalfunctionMay 5, 2022Material Fragmentation; Material Fragmentation

  THE MANUFACTURER RECEIVED NOTIFICATION OF A SYSTEM SCREWDRIVER MALFUNCTION ON (B)(6) 2022. IT WAS REPORTED THAT THE DISTAL TIP OF A SYSTEM SCREWDRIVER FRACTURED WHILE FINAL TIGHTENING AN IMPLANT DURING A PROCEDURE ON (B)(6) 2022. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THE COMPLAINT SCREWDRIVER WAS RECEIVED ON 4/22/2022 AT THE MANUFACTURER FOR COMPLAINT ASSESSMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14292741 ↗
• MalfunctionOct 21, 2021Material Fragmentation; Material Fragmentation

  THE MANUFACTURER RECEIVED NOTIFICATION OF A SYSTEM SCREWDRIVER MALFUNCTION ON (B)(6) 2021. IT WAS REPORTED THAT THE DISTAL TIP OF A SYSTEM SCREWDRIVER SHEARED OFF WHEN BEING USED FOR A CROSS CONNECTOR REMOVAL FROM AN ALTERNATE SURGICAL SYSTEM FROM THE MANUFACTURER. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. AN ALTERNATE AVAILABLE INSTRUMENT WAS USED TO SUCCESSFULLY COMPLETE THE SURGICAL PROCEDURE. THE TORQUE DRIVER HANDLE THAT WAS BEING USED WHEN THE INSTRUMENT MALFUNCTION OCCURRED, WAS ALSO REQUESTED TO BE RETURNED TO THE MANUFACTURER FOR COMPLAINT ASSESSMENT. THE COMPLAINT SCREWDRIVER AND TORQUE DRIVER HANDLE WERE RECEIVED ON 10/15/2021 AT THE MANUFACTURER FOR COMPLAINT ASSESSMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12675781 ↗
• MalfunctionMay 6, 2021Material Fragmentation; Material Fragmentation

  THE COMPANY RECEIVED NOTIFICATION ON (B)(6) 2021 THAT THE DISTAL TIPS OF TWO SYSTEM SCREWDRIVERS FRACTURED WHILE BEING USED TO FINAL TIGHTEN A SYSTEM IMPLANT. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AVAILABLE ALTERNATE INSTRUMENTS. THE TORQUE LIMITING HANDLES THAT WERE BEING USED WHEN THE MALFUNCTION OCCURRED WERE REQUESTED TO BE RETURNED TO THE COMPANY WITH THE COMPLAINT INSTRUMENTS. THIS MDR IS ASSOCIATED WITH REPORTS 3005031160-2021-00007, 3005031160-2021-00009, AND 3005031160-2021-00010.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787391 ↗
• MalfunctionMay 6, 2021Material Fragmentation; Material Fragmentation

  THE COMPANY RECEIVED NOTIFICATION ON (B)(6) 2021 THAT THE DISTAL TIPS OF TWO SYSTEM SCREWDRIVERS FRACTURED WHILE BEING USED TO FINAL TIGHTEN A SYSTEM IMPLANT. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AVAILABLE ALTERNATE INSTRUMENTS. THE TORQUE LIMITING HANDLES THAT WERE BEING USED WHEN THE MALFUNCTION OCCURRED WERE REQUESTED TO BE RETURNED TO THE COMPANY WITH THE COMPLAINT INSTRUMENTS. THIS MDR IS ASSOCIATED WITH REPORTS 3005031160-2021-00008, 3005031160-2021-00009, AND 3005031160-2021-00010.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787362 ↗
• MalfunctionMay 6, 2021Material Fragmentation; Material Fragmentation

  THE COMPANY RECEIVED NOTIFICATION ON (B)(6) 2021 THAT THE DISTAL TIP OF A SYSTEM SCREWDRIVER FRACTURED WHILE BEING USED TO FINAL TIGHTEN A SYSTEM IMPLANT. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AVAILABLE ALTERNATE INSTRUMENTS. THE TORQUE LIMITING HANDLES THAT WERE BEING USED WHEN THE MALFUNCTION OCCURRED WERE REQUESTED TO BE RETURNED TO THE COMPANY WITH THE COMPLAINT INSTRUMENTS. THIS MDR IS ASSOCIATED WITH REPORTS 3005031160-2021-00007, 3005031160-2021-00008, AND 3005031160-2021-00009.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787357 ↗
• MalfunctionMay 6, 2021Material Fragmentation; Material Fragmentation

  THE COMPANY RECEIVED NOTIFICATION ON (B)(6) 2021 THAT THE DISTAL TIP OF A SYSTEM SCREWDRIVER FRACTURED WHILE BEING USED TO FINAL TIGHTEN A SYSTEM IMPLANT. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS COMPLAINT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AVAILABLE ALTERNATE INSTRUMENTS. THE TORQUE LIMITING HANDLES THAT WERE BEING USED WHEN THE MALFUNCTION OCCURRED WERE REQUESTED TO BE RETURNED TO THE COMPANY WITH THE COMPLAINT INSTRUMENTS. THIS MDR IS ASSOCIATED WITH REPORTS 3005031160-2021-00007, 3005031160-2021-00008, AND 3005031160-2021-00010.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787338 ↗
• MalfunctionMay 13, 2020Material Fragmentation; Material Fragmentation

  THE COMPANY RECEIVED COMMUNICATION ON (B)(6) 2020 REGARDING AN INSTRUMENT MALFUNCTION. IT WAS REPORTED THAT THE DISTAL TIP OF A SYSTEM SCREWDRIVER FRACTURED FROM THE BODY OF THE INSTRUMENT. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS PRODUCT COMPLAINT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10053680 ↗
• MalfunctionApr 10, 2020Fracture; Fracture

  THE COMPANY RECEIVED NOTIFICATION ON (B)(6) 2020 REGARDING THE DISTAL TIP OF A SYSTEM SCREWDRIVER FRACTURING WHILE BEING USED IN A SURGICAL PROCEDURE ON (B)(6) 2020. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN PROCEDURE. THERE WAS AN ALTERNATE INSTRUMENT AVAILABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9948767 ↗
• MalfunctionMar 26, 2019No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE COMPLAINANT REPORTED THAT THEY HAD SCREWDRIVERS THAT WERE REPORTED TO BE BROKEN AND TWISTED. THE COMPLAINANT WAS UNABLE TO PROVIDE SPECIFIC DETAILS REGARDING THE INSTRUMENTS. THERE WERE NO KNOWN PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8454574 ↗
• MalfunctionMar 7, 2019Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  THE DISTAL END OF A SCREWDRIVER TWISTED AND FRACTURED OFF DURING PLACEMENT OF A SCREW. THERE WERE NO KNOWN COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8400905 ↗
• MalfunctionDec 26, 2018Break; Break

  THE COMPLAINANT REPORTED THAT THE T-HANDLE IN THEIR POSSESSION IS OUT OF CALIBRATION AND RESULTED IN TWO SCREWDRIVERS BREAKING. THERE WERE NO KNOWN PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8197729 ↗
• MalfunctionNov 20, 2018Fracture; Fracture

  THE COMPLAINANT REPORTED THAT THE DISTAL TIP OF THE SCREWDRIVER BROKE WHILE REMOVING A CROSSLINK FROM A PREVIOUS SURGERY. THERE WERE NO KNOWN PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8092204 ↗
• MalfunctionNov 14, 2018Fracture; Fracture

  THE COMPLAINANT REPORTED THAT A SCREWDRIVER BROKE WHILE REMOVING A CROSSLINK FROM A PREVIOUS SURGERY. THERE WERE NO KNOWN PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8070711 ↗
• MalfunctionSep 14, 2018Break; Fracture; Break; Fracture

  THE COMPLAINANT REPORTED THAT THE DISTAL TIP OF THE SCREWDRIVER BROKE WHILE INSERTING AN IMPLANT. THERE WERE NO KNOWN PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7877292 ↗
• MalfunctionJul 12, 2018Fracture; Improper or Incorrect Procedure or Method; Fracture; Improper or Incorrect Procedure or Method

  THE COMPLAINANT REPORTED THAT A SCREWDRIVER BROKE WHILE REMOVING A CROSS BAR CONNECTOR BETWEEN L3 AND L4. THERE WERE NO KNOWN PATIENT COMPLICATIONS ASSOCIATED WITH THIS INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7683123 ↗
• MalfunctionMay 15, 2018Break; Fracture; Break; Fracture

  THE COMPLAINANT REPORTED THAT DURING A REMOVAL OF A CROSSLINK FROM A PREVIOUS SURGERY, THE DRIVER BROKE IN THE CENTER SCREW HOLE WHEN THE SURGEON WAS TRYING TO REMOVE THE CROSSLINK. THE REMOVAL OF THE CROSSLINK WAS BEING PERFORMED AS PART OF A PLANNED REVISION SURGERY TO ADDRESS ADJACENT LEVEL DISEASE. THERE WAS NO DELAY IN SURGERY, AND THERE WERE NO KNOWN PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7516537 ↗
• MalfunctionApr 12, 2018Fracture; Fracture

  THE COMPLAINANT REPORTED A COMPLAINT FROM (B)(6). THE COMPLAINANT STATED THAT AN AXLE SCREWDRIVER (X060-0320) BROKE WHEN TIGHTENING THE LOCKING SCREW, AND THAT THE BROKEN PIECE WAS RECOVERED WITHOUT INCIDENT. THE COMPLAINANT ALSO ADDED THAT THE PROCEDURE WAS COMPLETED WITH A SECONDARY SCREWDRIVER AND THAT THE PATIENT WAS UNAFFECTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7426737 ↗