BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PWB ROD AND SCREW

    MDR report key: 13915 · Received June 10, 1994

    Report

    Report Number
    MW1002427
    Event Type
    Injury
    Date Received
    June 10, 1994
    Date of Event
    January 26, 1993
    Report Date
    May 6, 1994
    Manufacturer
    UNKNOWN
    Product Code
    MCV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TRANSPEDICULAR SCREW FRACTURED. IT WAS REMOVED ON 6/26/93. THE ENTIRE FIXATION DEVICE WAS LOOSE AND BONE GRAFTS FAILED. PHYSICIAN TRAINED BY PRACTICING ON A DUMMY. RPTR WAS HIS FIRST PT WITH THIS DEVICE. RPTR STATES SURGERY FOUND TO HAVE BEEN UNNECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PWB ROD AND SCREW Implant TRANSPEDICULAR SCREW MCV UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention| S