BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 1638219 · Received March 18, 2010

    Report

    Report Number
    MW5015231
    Event Type
    Injury
    Date Received
    March 18, 2010
    Date of Event
    September 30, 2008
    Report Date
    March 18, 2010
    Manufacturer
    MEDTRONIC
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC SCREWS WERE PART OF A SYSTEM TO SECURE MY L-5/S-1. ONE SCREW BROKE WHILE ON VERY LIMITED ACTIVITY WITHIN 3-4 MONTHS AFTER BEING PLACED IN MY BACK. A SECOND SCREW BROKE A FEW MONTHS AFTER THE FIRST. THE RODS WERE NOW ATTACHED BY ONE SCREW EACH AND NOT STABILIZING MY SPINE. I HAD TO UNDER GO A SECOND SURGERY TO REMOVE THE DEFECTIVE HARDWARE. PT FROM (B) (6) 2007- TODAY. DATES OF USE: (B) (6) 2008 -- (B) (6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC PEDICAL SCREW KWQ MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| O| R