BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXLE INTERSPINOUS FUSION SYSTEM

    MDR report key: 19931733 · Received August 7, 2024

    Report

    Report Number
    3005031160-2024-00028
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    July 8, 2024
    Report Date
    August 7, 2024
    Manufacturer
    XTANT MEDICAL HOLDINGS, INC
    Product Code
    HTC
    UDI-DI
    M697X06015201
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL ASSESSMENT OF THE RETURNED SYSTEM INSERTER/COMPRESSOR SHOWED AN INSTRUMENT WITH REPEATED USE, AS IDENTIFIED BY WORN LASER MARKINGS AND SURFACE SCRATCHES. THE DISTAL LIP OF THE INSTRUMENT WAS FRACTURED AND NOT PRESENT. A FUNCTIONALITY ASSESSMENT WAS NOT PERFORMED DUE TO THE DAMAGED CONDITION OF THE RETURNED INSTRUMENT, WHICH WAS REMOVED FROM DISTRIBUTABLE INVENTORY. A DHR REVIEW WAS PERFORMED FOR THE INSTRUMENT LOT WHICH MET ALL REQUIRED SPECIFICATIONS PRIOR TO BEING RELEASED TO DISTRIBUTABLE INVENTORY. THIS LOT HAS BEEN AVAILABLE FOR DISTRIBUTION SINCE 06/19/2023, RESULTING IN AN APPROXIMATE FIELD LIFE OF ONE YEAR. IT IS UNKNOWN HOW MANY USES THE DEVICE HAS UNDERGONE DURING THAT TIME. IT MAY BE POSSIBLE FOR THE OBSERVED INSTRUMENT MALFUNCTION TO OCCUR IF EXCESSIVE FORCE WAS PLACED ON THE SET SCREW THAT ENGAGES AND RETAINS THE SYSTEM IMPLANT TO THE INSERTER/COMPRESSOR. THE SET SCREW THAT ENGAGES AND RETAINS THE SYSTEM IMPLANT IS INTENDED TO BE TIGHTENED TO SECURELY RETAIN THE IMPLANT. IF FORCE IS APPLIED BEYOND WHAT IS REQUIRED TO SECURELY RETAIN THE IMPLANT, IT MAY RESULT IN THE DISTAL LIP OF THE INSTRUMENT TO MALFUNCTION AS OBSERVED. BASED ON THE INFORMATION REVIEWED, THE ROOT CAUSE OF THIS EVENT WAS DETERMINED TO BE AN UNINTENDED USER ERROR RELATED TO EXCESSIVE FORCE PLACED ON THE SET SCREW THAT ENGAGES AND RETAINS THE SYSTEM IMPLANT. THERE HAVE BEEN THREE OTHER COMPLAINTS OF SIMILAR NATURE FOR THIS INSTRUMENT IN THE PAST 12 MONTHS. THE MANUFACTURER WILL CONTINUE TO MONITOR THE FIELD FOR COMPLAINTS OF SYSTEM INSERTER/COMPRESSORS WITH BROKEN DISTAL LIPS.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552473 AXLE INTERSPINOUS FUSION SYSTEM PLIERS, SURGICAL HTC XTANT MEDICAL HOLDINGS, INC X060-1520 28747 M697X06015201

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male