BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEO PEDICLE SCREW SYSTEM

    MDR report key: 22666371 · Received July 30, 2025

    Report

    Report Number
    3013546462-2025-00003
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    June 30, 2025
    Report Date
    July 28, 2025
    Manufacturer
    NEO MEDICAL SA
    Product Code
    NKB
    UDI-DI
    07640177821027
    PMA / PMN Number
    K212489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCTION RECORDS FROM THE INVOLVED LOTS HAVE BEEN CHECKED AND FOUND NO ISSUES. INVESTIGATION IS STILL ONGOING, NO UNIQUE ROOT CAUSE WAS IDENTIFIED . WE BELIEVE THE ISSUE IS A COMBINATION OF MIS-HANDLING FROM SURGEONS NOT FOLLOWING THE SURGICAL TECHNIQUE RESULTING IN A HIGHER FRICTION IN THE SET-SCREWDRIVER THAT LEADS TO A HIGHER TORQUE APPLIED ON THE TIP AND, IN FEW CASES, THE BREAKAGE OF THE TIP.

    Description of Event or Problem · 0

    DURING A MINIMALLY INVASIVE REVISION SURGERY DUE TO AN ADJACENT LEVEL FRACTURE, THE INITIAL CONSTRUCT WAS TO BE REMOVED AND REPLACED. WHILE ATTEMPTING TO REMOVE THE LOCKING SCREWS FROM THE ORIGINALLY PLACED 10-SCREW CONSTRUCT, ONE OF THE SCREWS PROVED DIFFICULT TO EXTRACT. IT WAS EVENTUALLY DISCOVERED THAT THE LOCKING SCREW CONTAINED A BROKEN SET SCREWDRIVER TIP. DESPITE THIS COMPLICATION, THE ENTIRE CONSTRUCT WAS SUCCESSFULLY REMOVED WITH CONSIDERABLE EFFORT. THE INITIAL SURGERY, WHICH WAS ALSO PERFORMED MINIMALLY INVASIVELY, WAS SUPPORTED ON-SITE BY A COMPANY REPRESENTATIVE. NO IRREGULARITIES WERE NOTED DURING THE FINAL FIXATION OF THE SET SCREW AT THAT TIME. IT WAS REPORTED THIS EVENT DIDN'T IMPACT THE PATIENT OUTCOME. ALSO, NO PATIENT PAIN RELATED TO IMPLANT WAS REPORTED IN BETWEEN THE INITIAL SURGERY AND THE REVISION SURGERY. HOWEVER, WE LEARNED THAT THE REVISION SURGERY TOOK LONGER THAN EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496321 NEO PEDICLE SCREW SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB NEO MEDICAL SA PEDICLE SCREW KIT 2024066818 07640177821027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male SC-60-30-PE