BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARSENAL SPINAL FIXATION SYSTEM

    MDR report key: 21688570 · Received March 25, 2025

    Report

    Report Number
    2027467-2025-00036
    Event Type
    Malfunction
    Date Received
    March 25, 2025
    Date of Event
    February 25, 2025
    Report Date
    March 25, 2025
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    HXX
    UDI-DI
    00840967197906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DRIVER HAS NOT RETURNED FOR EVALUATION. PHOTOGRAPHS WERE NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE IDENTIFYING LOT NUMBER WAS NOT PROVIDED. ALPHATEC SPINE IS SUBMITTING THIS REPORT TO COMPLY WITH THE FDA REGULATIONS 21 CFR 803. ALPHATEC SPINE HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS AVAILABLE. ANY FIELD THAT IS LEFT BLANK WAS NOT KNOWN AT THE TIME OF THIS SUBMISSION. IF ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1695439 ARSENAL SPINAL FIXATION SYSTEM SCREWDRIVER HXX ALPHATEC SPINE, INC. 87134 00840967197906

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown