BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD PARKER

    MDR report key: 3150099 · Received April 25, 2013

    Report

    Report Number
    1836161-2013-00116
    Event Type
    Malfunction
    Date Received
    April 25, 2013
    Date of Event
    March 5, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GES
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT SCHEDULED FOR ELECTIVE DECOMPRESSIVE LAMINECTOMY WITH RADICAL DISCECTOMY AND ARTHRODESIS WITH INSTRUMENTATION. WHILE IN SURGERY, BLADE BROKE. ADDITIONAL DOCTORS CONSULTED. FOREIGN BODY IS LOCATED IN A RETROPERITONEAL POSITION AND MAY WELL BE DIFFICULT TO LOCATE INTRAOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179058 BARD PARKER #11 SCALPEL GES ASPEN SURGICAL PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R