BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOHNSON & JOHNSON

    MDR report key: 2960594 · Received February 7, 2013

    Report

    Report Number
    MW5028940
    Event Type
    Injury
    Date Received
    February 7, 2013
    Date of Event
    August 7, 2012
    Report Date
    February 7, 2013
    Manufacturer
    DEPUY
    Product Code
    MAX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE HAD 5 BACK OPERATIONS. THE FIRST ONE WAS TO TAKE A TUMOR OFF OF MY SPINE. NO HARDWARE WAS USED, I RETURNED TO WORK AND BROKE MY BACK. I THEN HAD RODS AND SCREWS PUT IN. I WAS ALMOST TO THE POINT OF NOT ABLE TO WALK AND HAD LONGER RODS AND SCREWS PUT IN. AGAIN I WAS IN SO MUCH PAIN I WAS UNABLE TO WORK AND HAD ANOTHER OPERATION WHICH THE PHYSICIAN FOUND LOOSE SCREWS. ON (B)(6) 2012, I UNDERWENT ANOTHER OPERATION WHICH FOUND BROKEN RODS AND MORE HARDWARE WAS PLACED. MY PHYSICIAN SAID HE WAS SORRY AND SHOULD HAVE EXTENDED IT BEFORE ON (B)(6) 2012. I DO KNOW OF SOMEONE WHO HAD BROKEN RODS REPLACED IN 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51439 JOHNSON & JOHNSON LUMBAR FUSION MAX DEPUY

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R| S