BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXLE INTERSPINOUS FUSION SYSTEM

    MDR report key: 20323072 · Received September 27, 2024

    Report

    Report Number
    3005031160-2024-00033
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    August 29, 2024
    Report Date
    September 27, 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
    US
    Reporter Occupation
    003

    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 AS REPORTED. THE DISTAL LIP THAT WAS FRACTURED DURING THE PROCEDURE WAS NOT RETURNED TO THE MANUFACTURER FOR ASSESSMENT. 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 02/09/2021 , RESULTING IN AN APPROXIMATE LIFE OF 3.5 YEARS. 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 INSTRUMENT SET SCREW THAT ENGAGES AND RETAINS THE CROSS BAR PLATE IMPLANT TO THE INSERTER/COMPRESSOR. THE SET SCREW THAT ENGAGES AND RETAINS THE CROSS BAR PLATE 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. THE ROOT CAUSE OF THIS COMPLAINT APPEARS TO BE THAT THE SIDE SCREW OF THE ARTICULATING ARM WAS OVERTIGHTENED WHEN SECURING THE CROSS BAR PLATE TO THE ARM, LEADING TO THE DISTAL LIP OF THE INSERTER TO BREAK OFF. THE SURGICAL TECHNIQUE FOR THIS SYSTEM SPECIFICALLY WARNS NOT TO OVERTIGHTEN THE SET SCREW FOR THIS REASON. THERE HAVE BEEN 5 OTHER COMPLAINTS OF SIMILAR NATURE FOR THIS INSTRUMENT IN THE PAST 12 MONTHS. THE MANUFACTURER WILL CONTINUE TO MONITOR THE FIELD FOR COMPLAINTS OF FRACTURED DISTAL LIPS.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1685147 AXLE INTERSPINOUS FUSION SYSTEM PLIERS ALL-IN-ONE, INSERTER/COMPRESSOR ASSEMBLY HTC XTANT MEDICAL HOLDINGS, INC. X060-1520 21179 M697X06015201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other X060-1520 PLIERS ALL-IN-ONE, INSERTER/COMPRESSOR A.