BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSX INTERBODY SYSTEM

    MDR report key: 15591101 · Received October 12, 2022

    Report

    Report Number
    2027467-2022-00071
    Event Type
    Malfunction
    Date Received
    October 12, 2022
    Date of Event
    September 13, 2022
    Report Date
    September 13, 2022
    Manufacturer
    ALPHATEC SPINE, INC
    Product Code
    MAX
    PMA / PMN Number
    K211873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE EVALUATION POSSIBLE AS IMPLANT REMAINS IN-SITU. A RADIOGRAPH WAS PROVIDED TO CONFIRM THE EVENT. NEITHER THE PART NOR LOT NUMBERS WERE PROVIDED. BASED ON THE INFORMATION PROVIDED, A ROOT CAUSE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AT THE 6-WEEK FOLLOW-UP VISIT, A RADIOGRAPH REVEALED THE CAGE HAD MIGRATED AROUND 3MM. THE PATIENT ASYMPTOMATIC. THE SURGEON WILL CONTINUE TO MONITOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2494756 PSX INTERBODY SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX ALPHATEC SPINE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown