BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREMAX-SA CENTRAL THREADED ROD INSTRUMENT

    MDR report key: 21148123 · Received January 14, 2025

    Report

    Report Number
    3013961579-2025-00001
    Event Type
    Malfunction
    Date Received
    January 14, 2025
    Date of Event
    December 4, 2024
    Report Date
    January 14, 2025
    Manufacturer
    ADDITIVE IMPLANTS
    Product Code
    LYQ
    UDI-DI
    817662025773
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING SURGERY, THE CENTRAL THREADED ROD INSTRUMENT DISTAL TIP BROKE DURING THE FINAL SEATING OF A CERVICAL SPACER. THE CENTRAL THREADED ROD DISTAL TIP BROKE WHILE TRYING TO MANIPULATE THE SPACER INTO POSITION. THE TIP OF THE INSTRUMENT REMAINS IN THE SPACER (RETAINED PIECE). SURGEON USED A TAMP INSTRUMENT TO COMPLETE THE FINAL SEATING OF THE SPACER. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1255538 SUREMAX-SA CENTRAL THREADED ROD INSTRUMENT ACCESSORIES, FIXATION, SPINAL INTERVERTEBRAL BODY LYQ ADDITIVE IMPLANTS 210231 817662025773

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown