BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSETO-SITE BONE BIOSPY NEEDLE

    MDR report key: 379979 · Received March 6, 2002

    Report

    Report Number
    1820334-2002-00031
    Event Type
    Injury
    Date Received
    March 6, 2002
    Date of Event
    January 10, 2002
    Report Date
    January 10, 2002
    Manufacturer
    COOK INC
    Product Code
    DWO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A VERTEBRAL PLASTY OF T-11 WAS PERFORMED FOR A T-11 COMPRESSION FRACTURE. THE OSTEO-SITE BONE BIOPSY NEEDLE WAS USED DURING THE PROCEDURE, UPON ATTEMPTED WITHDRAWAL THE BLUE T-HANDLE BROKE FROM THE CANNULA. REMOVAL INSTRUMENTATION WAS OBTAINED FROM THE OPERATING ROOM AND THE CANNULA WAS REMOVED SUCCESSFULLY WITHOUT ANY INJURY TO THE PT. THE PT WAS DISCHARGED IN SATISFACTORY CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSETO-SITE BONE BIOSPY NEEDLE NEEDLE DWO COOK INC NA 1089533

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention