BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXLE INTERSPINOUS FUSION SYSTEM

    MDR report key: 19744288 · Received July 15, 2024

    Report

    Report Number
    3005031160-2024-00025
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    June 5, 2024
    Report Date
    July 15, 2024
    Manufacturer
    XTANT MEDICAL HOLDINGS, INC.
    Product Code
    HXX
    UDI-DI
    M697X06003201
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TWO (2) AIO INSERTERS AND ONE (1) SCREWDRIVER WERE RETURNED TO XTANT FOR EVALUATION AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EVALUATION OF THE INSERTERS IDENTIFIED A FRACTURED AND MISSING DISTAL LOCKING PLATE RETENTION FEATURE ON ONE INSERTER, AND A FRACTURED AND MISSING CROSS BAR PLATE RETENTION FEATURE ON THE OTHER INSERTER. FURTHER, EVALUATION OF THE SCREWDRIVER IDENTIFIED A FRACTURED AND MISSING DISTAL TIP ALONG WITH TWISTING OF THE REMAINING DISTAL PORTION, INDICATING EXCESSIVE ROTATIONAL FORCE APPLIED TO THE DEVICE. SIGNS OF WEAR WERE APPARENT ACROSS ALL THREE INSTRUMENTS, INCLUDING SCRATCHES AND ABRASIONS ACROSS THE SURFACES AND MINOR DISCOLORATION AND FADING OF THE LASER MARKINGS. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. IT WAS REPORTED THAT THE SURGEON TIGHTENED DOWN ON THE WRONG SCREW DURING ASSEMBLY OF THE INSERTER WITH THE IMPLANT PLATE ON MORE THAN ONE OCCASION DURING THE CASE. IT WAS NOTED THAT THIS IMPROPER USE CONTRIBUTED TO THE FRACTURE OF THE FIRST INSERTER AND THE SCREWDRIVER TIP. ADDITIONALLY, IT WAS NOTED THE SURGEON APPLIED EXCESSIVE COMPRESSION DURING IMPLANT PLACEMENT, CONTRIBUTING TO THE FRACTURE OF THE SECOND INSERTER. IT IS UNKNOWN IF THE TORQUE LIMITING HANDLE WAS USED DURING TIGHTENING. A REVIEW OF MANUFACTURING RECORDS FOR THE INSERTER DEVICES WAS PERFORMED AND NO DEVIATIONS WERE IDENTIFIED. THE AIO INSERTERS WERE RELEASED TO THE FIELD IN OCTOBER 2022, RESULTING IN AN APPROXIMATE FIELD LIFE OF TWO (2) YEARS. IT IS UNKNOWN HOW MANY USES THE INSTRUMENTS HAVE UNDERGONE AFTER RELEASE TO THE FIELD. FURTHER, REVIEW OF MANUFACTURING RECORDS FOR THE SCREWDRIVER DEVICE WAS PERFORMED AND NO DEVIATIONS WERE IDENTIFIED. THE SCREWDRIVER RELEASED TO THE FIELD IN JANUARY 2020, RESULTING IN AN APPROXIMATE FIELD LIFE OF FOUR (4) YEARS. IT IS UNKNOWN HOW MANY USES THE INSTRUMENT HAD UNDERGONE AFTER RELEASE TO THE FIELD. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THIS EVENT WAS DETERMINED TO BE AN UNINTENDED USER ERROR RELATED TO EXCESSIVE FORCE APPLIED TO THE INSTRUMENTS DURING TIGHTENING OF THE IMPROPER SCREW AND COMPRESSION OF THE SYSTEM IMPLANT. THE IFU FOR THE AXLE INTERSPINOUS FUSION SYSTEM WARNS "THE SURGEON SHOULD HAVE A COMPLETE UNDERSTANDING OF THE FUNCTION AND LIMITATIONS OF EACH IMPLANT AND INSTRUMENT. DEVICE COMPONENTS SHOULD BE RECEIVED AND ACCEPTED ONLY IN PACKAGES THAT HAVE NOT BEEN DAMAGED OR TAMPERED WITH. DAMAGED IMPLANTS AND/OR INSTRUMENTS SHOULD NOT BE USED. COMPONENTS MUST BE CAREFULLY HANDLED AND STORED IN A MANNER THAT PREVENTS SCRATCHES, DAMAGE, AND CORROSION". ADDITIONALLY, "BREAKAGE, SLIPPAGE, OR MISUSE OF INSTRUMENTS OR IMPLANT COMPONENTS MAY CAUSE INJURY TO THE PATIENT OR OPERATIVE PERSONNEL". IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285223 AXLE INTERSPINOUS FUSION SYSTEM SCREWDRIVER HXX XTANT MEDICAL HOLDINGS, INC. X060-0320 100835 M697X06003201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown INSERTER, C060-0010