BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW

    MDR report key: 2800376 · Received October 22, 2012

    Report

    Report Number
    2800376
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    September 12, 2012
    Report Date
    October 3, 2012
    Manufacturer
    OMNI SURGICAL SPINE 360
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A (B)(6) FEMALE WITH HISTORY OF SPONDYLOLISTHESIS, COMPLAINING OF LOWER BACK PAIN AND RIGHT LEG NUMBNESS AND TINGLING. PATIENT ADMITTED FOR REVISION OF A PREVIOUS INSTRUMENTATION, L5 S1. PER SURGEON, RADICULOPATHY OF NEW ONSET DISPLACEMENT OF INTERBODY CAGE INTO THE AREA OF THE ROOT AND WITH RADICULOPATHY AND BROKEN OF THE S1 SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDICLE SCREW BONE SCREWS NKB OMNI SURGICAL SPINE 360 4057

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R