BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEGACY FUSION SCREW

    MDR report key: 1132843 · Received August 22, 2008

    Report

    Report Number
    MW5008063
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 3, 2008
    Report Date
    August 11, 2008
    Manufacturer
    MEDTRONIC
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD HARDWARE IN LUMBAR SPINE. COMPLAINED OF PAIN. SURGEON PERFORMED SURGERY AND FOUND BROKEN SCREW. HARDWARE REMOVED AND NEW HARDWARE PLACED, SCREW BROKEN. DIAGNOSIS OR REASON FOR USE: SPONDYLOLISTHESIS L5-S1. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC LEGACY FUSION SCREW LEGACY FUSION SCREW KWP MEDTRONIC 7.5X3.5 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization