Axle Interspinous Fusion SystemRecalls & reported problems across all models
Xtant Medical Holdings, Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 55
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 7 models of Axle Interspinous Fusion System by Xtant Medical Holdings, Inc. in the FDA's device registry (GUDID). Together they are named in 55 adverse event reports in the FDA's MAUDE database, received between Apr 12, 2018 and Apr 23, 2025 — classified as 55 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (28 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Axle Interspinous Fusion System problems
Device problems
- Material Fragmentation28
- Fracture17
- Break11
- Difficult or Delayed Separation1
- Improper or Incorrect Procedure or Method1
- Insufficient Device Problem Information1
- Material Integrity Problem1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- No Known Impact Or Consequence To Patient17
- No Consequences Or Impact To Patient1
Axle Interspinous Fusion System models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Axle Interspinous Fusion System X060-0320SCREWDRIVER25 reports
- Axle Interspinous Fusion System X060-1520Pliers, Surgical19 reports
- Axle Interspinous Fusion System X060-0370INSTRUMENT, COMPRESSION4 reports
- Axle Interspinous Fusion System X060-0318PLIERS, SURGICAL3 reports
- Axle Interspinous Fusion System C060-0010Pliers, Surgical2 reports
- Axle Interspinous Fusion System X060-0080Spinous process plate1 report
- Axle Interspinous Fusion System X060-0241Spinous process plate1 report
Recent Axle Interspinous Fusion System adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗
Other Xtant Medical Holdings, Inc. products
All Xtant Medical Holdings, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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