BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSX INTERBODY SYSTEM

    MDR report key: 15567234 · Received October 7, 2022

    Report

    Report Number
    2027467-2022-00072
    Event Type
    Malfunction
    Date Received
    October 7, 2022
    Date of Event
    June 15, 2022
    Report Date
    June 15, 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 THE IMPLANT REMAINS IN THE PATIENT. A RADIOGRAPH WAS RECEIVED WHICH CONFIRMED THE EVENT. NEITHER THE IDENTIFYING PART NOR LOT NUMBER WERE PROVIDED; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE IS UNKNOWN. IF ADDITIONAL INFORMATION IS PROVIDED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED A CAGE COLLAPSED AROUND 2 MONTHS POSTOPERATIVELY. THE SURGEON WILL CONTINUE TO MONITOR THE PATIENT. THERE ARE NO PLANS FOR REVISION SURGERY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289139 PSX INTERBODY SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX ALPHATEC SPINE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown