BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPRESS MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

    MDR report key: 8092201 · Received November 20, 2018

    Report

    Report Number
    3005031160-2018-00034
    Event Type
    Malfunction
    Date Received
    November 20, 2018
    Date of Event
    October 25, 2018
    Report Date
    November 20, 2018
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    HXE
    UDI-DI
    M697X01001671
    PMA / PMN Number
    K152132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT REPORTED DIFFICULTIES REDUCING A ROD INTO A PEDICLE SCREW. THE SURGEON WAS UNABLE TO USE THE PERSUADER OR THE PISTOL GRIP REDUCER. THE SURGEON WAS ABLE TO REDUCE THE ROD USING A ROD FORK. THE ROD FORK WAS DAMAGED WHILE REDUCING THE ROD. THERE WERE NO KNOWN PATIENT COMPLICATIONS. THE COMPLAINT INSTRUMENTS WERE NOT RETURNED FOR COMPLAINT ASSESSMENT. THE COMPLAINANT PROVIDED PHOTOS OF THE INSTRUMENTS. THE PROCEDURE REQUIRED POSTERIOR INSTRUMENTATION FORM T9 TO L2. ROD CONTOURING FOR MULTI-LEVEL INSTRUMENTATION MUST BE PERFORMED SO THAT THE APEX OF A BENT ROD IS NOT IN THE LOCKING ZONE OF A PEDICLE SCREW. THE TECHNIQUE GUIDE INSTRUCTS THE END USER TO VERIFY THAT THE AREA AROUND THE SCREW TO BE FREE OF BONY PROTRUSIONS TO ENSURE FULL ENGAGEMENT OF INSTRUMENTS TO THE PEDICLE SCREW. ADDITIONALLY, THE STG INSTRUCTS THAT IF UNABLE TO REDUCE, CONSIDER ADDITIONAL ROD CONTOURING, SCREW RELOCATION OR IN SITU FUSION. DHR REVIEWS FOR THE PERSUADER AND ROD FORK COULD NOT BE PERFORMED, BECAUSE THE LOT NUMBER WAS NOT PROVIDED TO THE COMPANY. THE DHR FOR THE PERSUADER WAS REVIEWED, AND THERE WERE NOT MANUFACTURING ANOMALIES. THE PERSUADER MET ALL OF THE REQUIRED SPECIFICATIONS PRIOR TO RELEASING TO DISTRIBUTABLE INVENTORY.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED DIFFICULTIES REDUCING A ROD INTO A PEDICLE SCREW. THE SURGEON WAS UNABLE TO USE THE PERSUADER OR THE PISTOL GRIP REDUCER. THE SURGEON WAS ABLE TO REDUCE THE ROD USING A ROD FORK. THE ROD FORK WAS DAMAGED WHILE REDUCING THE ROD. THERE WERE NO KNOWN PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932798 XPRESS MINIMALLY INVASIVE PEDICLE SCREW SYSTEM PEDICLE SCREW SPINAL SYSTEM HXE X-SPINE SYSTEMS, INC. X010-0167 M697X01001671

    Patients

    Seq Age Sex Outcome Treatment
    1 Other