BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY SPINE

    MDR report key: 1009407 · Received March 4, 2008

    Report

    Report Number
    1009407
    Event Type
    Injury
    Date Received
    March 4, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 28, 2008
    Manufacturer
    DEPUY
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HISTORY OF PRESENT ILLNESS: THIS IS A MALE WHO PRESENTED TO MY OFFICE WITH A HISTORY OF ONGOING PROGRESSIVE LOW BACK PAIN WITH RIGHT LOWER EXTREMITY RADICULOPATHY. HE HAD FAILED FUSION AND FRACTURED HIS HARDWARE. ALL FINDINGS, NATURE OF THE PROBLEM, ALTERNATIVE THERAPY, SURGICAL AND NONSURGICAL OPTIONS, RISKS AND BENEFITS, LIMITATIONS, AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE SURGERY WERE ALL DISCUSSED WITH THE PT PREOPERATIVELY, AND HE REQUESTED TO PROCEED WITH THE SURGERY IN HOPES OF HELPING HIS CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY SPINE VIPER SYSTEM KWQ DEPUY SEE ATTACHED *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization