BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALPHATEC NAVIGATION INSTRUMENTS

    MDR report key: 21119080 · Received January 9, 2025

    Report

    Report Number
    2027467-2024-00177
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    December 5, 2024
    Report Date
    January 9, 2025
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    OLO
    UDI-DI
    00190376475202
    PMA / PMN Number
    K153603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 DURING A CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169744 ALPHATEC NAVIGATION INSTRUMENTS ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ALPHATEC SPINE, INC. 17950-N 00190376475202

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown