BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDENTITI

    MDR report key: 20472691 · Received October 17, 2024

    Report

    Report Number
    2027467-2024-00126
    Event Type
    Malfunction
    Date Received
    October 17, 2024
    Date of Event
    September 18, 2024
    Report Date
    October 17, 2024
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    OVD
    UDI-DI
    00190376382982
    PMA / PMN Number
    K203742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSERTER 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. THE ROOT CAUSE COULD NOT BE DETERMINED. 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 INSERTER IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288222 IDENTITI INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR OVD ALPHATEC SPINE, INC. 233-150 00190376382982

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown