BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIVOX SPINAL SYSTEM

    MDR report key: 22666043 · Received July 30, 2025

    Report

    Report Number
    MW5173526
    Event Type
    Injury
    Date Received
    July 30, 2025
    Report Date
    July 28, 2025
    Manufacturer
    ALPHATEC SPINE
    Product Code
    MAX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE HAD ADDITIONAL PROBLEMS FOR HAVING THIS SURGERY I HAVE HAD TO HAVE NECK SPINAL SURGERY AND NOW I HAVE TO HAVE SACROILIAC (SI) JOINT FUSION SURGERY TO RELIEVE THE PAIN I¿M UNABLE TO WALK AND STAND WITHOUT NUMBNESS I CAN¿T PICK UP MORE THAN 10 POUNDS WITHOUT PAIN I WAS LET GO FROM MY JOB DUE TO NOT BEING ABLE TO PROPERLY PERFORM; 6. LOT, SERIAL, OR PART NUMBERS: (B)(6). I HAD THIS SURGERY ON (B)(6) 2021 FROM THE BEGINNING OF THIS SURGERY I HAVE NEVER BEEN ABLE TO STOP HURTING. I CAN¿T WALK WITHOUT MY LEGS AND BACK GETTING NUMBNESS PAIN SHOOTING DOWN MY LEGS. I HAVE FELL IN THE PAST DUE TO THIS PROCEDURE I¿M UNABLE TO SLEEP DUE TO THE PAIN. I¿M UNABLE TO SIT WITHOUT PAIN, I HAVE HAD ADDITIONAL SURGERY BECAUSE OF THIS PROCEDURE. I HAVE NECK SURGERY TO TRY TO RELIEVE THE PAIN, IT DIDN'T WORK. I HAVE ANOTHER SURGERY COMING UP CAUSE OF THE PAIN IN MY BACK. I HAVE BEEN RECEIVING PAIN MEDICINE FROM MY PAIN DOCTOR NOTHING HELPS. I HAVE SHOTS IN MY SPINE NOTHING WORKS. I HAVE LOST MY JOB OF 20 YEARS DUE TO THE FACT I¿M UNABLE TO DO MY JOB DUTY, THIS HAS CAUSED ME SO MUCH ANXIETY AND STRESS CAUSE I¿M NOT ABLE TO CARE FOR MY MYSELF AND KIDS. REF REPORTS: MW5173524, MW5173525.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496688 PIVOX SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX ALPHATEC SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown