BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTEX PEDICLE SCREW SYSTEM

    MDR report key: 19801357 · Received July 22, 2024

    Report

    Report Number
    3005031160-2024-00027
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    June 25, 2024
    Report Date
    July 22, 2024
    Manufacturer
    XTANT MEDICAL HOLDINGS, INC
    Product Code
    HXX
    UDI-DI
    M697X07000401
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SCREWDRIVER WAS RETURNED TO XTANT FOR EVALUATION AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EVALUATION OF THE DRIVER IDENTIFIED A FRACTURED AND MISSING DISTAL TIP, ALONG WITH TWISTING OF THE REMAINING DISTAL PORTION IN THE COUNTER-CLOCKWISE DIRECTION, INDICATING EXCESSIVE ROTATIONAL FORCE APPLIED TO THE DEVICE DURING THE ATTEMPTED LOOSENING OF A SET SCREW. SIGNS OF WEAR WERE APPARENT INCLUDING SCRATCHES AND ABRASIONS ACROSS THE SURFACE AND MINOR DISCOLORATION AND FADING OF THE LASER MARKINGS. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. IT IS UNKNOWN IF A TORQUE LIMITING HANDLE OR HAND TIGHTENING WAS USED WHEN THE MALFUNCTION OCCURRED. A REVIEW OF MANUFACTURING RECORDS FOR THE DEVICE WAS PERFORMED AND NO DEVIATIONS WERE IDENTIFIED. THE SCREWDRIVER RELEASED TO THE FIELD IN FEBRUARY 2012, RESULTING IN AN APPROXIMATE FIELD LIFE OF TWELVE (12) YEARS. IT IS UNKNOWN HOW MANY USES THE INSTRUMENT HAD UNDERGONE AFTER RELEASE TO THE FIELD. NO FURTHER INVESTIGATION WAS ABLE TO BE COMPLETED AT THIS TIME. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED WITH THE INFORMATION PROVIDED; HOWEVER, MAY HAVE BEEN RELATED TO EXCESSIVE FORCE APPLIED TO THE INSTRUMENT. AS DOCUMENTED IN THE IFU FOR THE FORTEX SYSTEM "INSPECTION AND TRIAL ASSEMBLY ARE RECOMMENDED PRIOR TO SURGERY TO DETERMINE IF INSTRUMENTS OR IMPLANTS HAVE BEEN DAMAGED." ADDITIONALLY, THE IFU WARNS "BY THE MECHANISM OF FATIGUE, THESE STRESSES CAN CAUSE EVENTUAL BENDING, LOOSENING OR BREAKAGE OF THE DEVICE(S)." 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 A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE AT A LEVEL ADJACENT TO AN EXISTING POSTERIOR FIXATION CONSTRUCT. DURING THE REMOVAL OF A CROSS LINK, IT WAS NOTED THAT THE DISTAL TIP OF THE CROSS LINK DRIVER FRACTURED OFF. NO PIECES WERE RETAINED BY THE PATIENT. A SPARE DRIVER WAS USED TO FINISH THE REMAINDER OF THE SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2466835 FORTEX PEDICLE SCREW SYSTEM SCREWDRIVER HXX XTANT MEDICAL HOLDINGS, INC X070-0040 L5051 M697X07000401

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female