BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COREX HSD

    MDR report key: 1622955 · Received February 18, 2010

    Report

    Report Number
    1622955
    Event Type
    Malfunction
    Date Received
    February 18, 2010
    Date of Event
    February 8, 2010
    Report Date
    February 18, 2010
    Manufacturer
    TRINITY ORTHOPEDICS, LLC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    OR TECH ON ADVICE OF SURGEON OPENED A BONE GRAFT HARVESTER ONTO THE STERILE FIELD. THIS PRODUCT WAS BROUGHT IN BY TRINITY REP. IT WAS FOUND LATER TO BE MARKED EXPIRED IN AUGUST 2009. WITHOUT KNOWLEDGE OF THE CIRCULATING NURSE, THIS PRODUCT WAS OPENED ONTO A STERILE FIELD ON A BACK TABLE. THE CASE WAS LATER ABORTED DUE TO PATIENT GOING INTO COMPLETE HEART BLOCK UNRELATED TO PRODUCT. THE PRODUCT NEVER ACTUALLY REACHED THE PATIENT OR FIELD NEAR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COREX HSD INSTRUMENT, SURGICAL, BONE HARVESTER LXH TRINITY ORTHOPEDICS, LLC * 9423299

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR