BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEO PEDICLE SCREW SYSTEM

    MDR report key: 22675448 · Received July 31, 2025

    Report

    Report Number
    3013546462-2025-00004
    Event Type
    Injury
    Date Received
    July 31, 2025
    Date of Event
    July 3, 2025
    Report Date
    July 30, 2025
    Manufacturer
    NEO MEDICAL SA
    Product Code
    NKB
    UDI-DI
    07640177820143
    PMA / PMN Number
    K212489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BU
    Reporter Occupation
    OTHER

    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 DUE TO SURGEON NOT FOLLOWING THE SURGICAL TECHNIQUE RESULTING LACK OF FIXATION OF THE SET-SCREWS IN THE INITIAL IMPLANTATION FOLLOWED BY LOOSENING OF THE CONSTRUCT. THE WRONG HANDLING MIGHT ALSO BE THE CAUSE OF THE BREAKAGE OF THE SET-SCREWDRIVER TIP.

    Description of Event or Problem · 0

    BREAKAGE OF A SCREWDRIVER TIP, LOOSED STABILIZATION NECESSITATING REVISION TWO MONTHS AFTER INITIAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2278659 NEO PEDICLE SCREW SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB NEO MEDICAL SA PEDICLE SCREW KIT 2024072128 07640177820143

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention