AXLE INTERSPINOUS FUSION SYSTEM

Description of Event or Problem

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.

Additional Manufacturer Narrative

VISUAL AND FUNCTIONAL ASSESSMENTS WERE NOT PERFORMED DUE TO THE SYSTEM INSERTER/COMPRESSOR NOT BEING RETURNED TO THE MANUFACTURER. A DHR REVIEW WAS NOT PERFORMED DUE TO NO COMMUNICATIONS OF THE SYSTEM INSERTER/COMPRESSOR NOT FUNCTIONING AS INTENDED AND THE LOT NUMBER NOT BEING AVAILABLE. IT COULD BE POSSIBLE FOR THE SYSTEM INSERTER/COMPRESSOR TO NOT BE EFFECTIVELY DISENGAGED FROM AN IMPLANT IF THE INSTRUMENT SET SCREWS WERE NOT APPROPRIATELY ROTATED OR IF THERE WAS NOT ADEQUATE SPACE TO MANIPULATE THE INSERTER FROM THE IMPLANT AFTER BEING PLACED. THE SYSTEM INSERTER/COMPRESSOR HAS TWO COMPRESSING ARMS THAT EACH ENGAGE WITH THE IMPLANT WITH SET SCREWS. IF EITHER OF THE SET SCREWS ARE NOT APPROPRIATELY ROTATED, IT CAN PRESENT DIFFICULTY BEING EFFECTIVELY DISENGAGED FROM THE PLACED IMPLANT. THE SYSTEM INSERTER/COMPRESSOR ENGAGES THE SYSTEM IMPLANT CONSTRUCT LATERALLY FROM BOTH SIDES FOR IMPLANTATION AND COMPRESSION. AFTER IMPLANT PLACEMENT AND COMPRESSION, THE SYSTEM INSERTER/COMPRESSOR MUST BE OPENED ENOUGH TO PASS BY THE SIDES OF THE IMPLANT FOR DISENGAGEMENT. IT MAY BE POSSIBLE THAT THE SURGEON'S PREFERRED TECHNIQUE DOES NOT ALLOW FOR ADEQUATE SPACE TO DISENGAGE THE SYSTEM INSERTER/COMPRESSOR WITHOUT DIFFICULTY. THE ROOT CAUSE OF THE DISENGAGEMENT ISSUE WITH THE SYSTEM INSERTER/COMPRESSOR COULD NOT BE RELIABLY DETERMINED. THE COMPLAINT INVESTIGATION SUGGESTS THAT THE INSERTER WAS NOT EFFECTIVELY DISENGAGED FROM THE IMPLANT, OR THAT THE SURGEON'S PREFERRED TECHNIQUE LEAVES LITTLE SPACE FOR THE INSTRUMENT TO BE EFFECTIVELY DISENGAGED FROM THE SYSTEM IMPLANT. THERE HAVE NOT BEEN ANY OTHER COMPLAINTS OF SIMILAR NATURE IN THE PAST 12 MONTHS. THE MANUFACTURER WILL CONTINUE TO MONITOR FOR REPORTS OF IMPLANTS NOT BEING EFFECTIVELY DISENGAGED FROM SYSTEM INSERTERS AND PERFORM COMPLAINT INVESTIGATIONS AS APPROPRIATE.