BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOPERSERVED LEFT FOREARM RADIUS BONE

    MDR report key: 441387 · Received February 5, 2003

    Report

    Report Number
    MW1027450
    Event Type
    Injury
    Date Received
    February 5, 2003
    Date of Event
    December 13, 2002
    Report Date
    February 5, 2003
    Manufacturer
    NORTHWEST TISSUE CENTER
    Product Code
    LMO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON SPECIAL ORDER A LEFT RADIUS FOREARM FROM TISSUE CENTER WITH ASSISTANCE OF A THIRD PARTY VENDOR. CRYOPRSERVED PACKAGE FROM TISSUE CENTER PRESENTED BY THIRD-PARTY VENDOR LABELED LEFT RADIUS FOREARM. PACKAGE CONFIRMED BY SURGEON AND VENDOR REP PRIOR TO SURGERY. THEN VENDOR AGENT CONFIRMED BONE PACKAGE WITH TISSUE CENTER. PT IN OR SUITE AND PROCEDURE BEGINS. INTRAOPERATIVELY STERILE-SEALED AND LABELED PACKAGE OPENED AND BONE FOUND NOT TO BE A LEFT RADIUS AS ORDERED AND LABELED BUT IN FACT A RIGHT RADIUS IN ERROR. PROBLEM: INCORRECTLY LABELED ALLOGRAFT PACKAGE BASED UPON ACTUAL CONTENTS. WAS TO BE A LEFT RADIUS FOREARM AS LABELED AND NOT A RIGHT RADIUS FOREARM AS FOUND WITHIN. OUTCOME: PT RECOVERED ON THAT DATE. RETURNED TO OR AT A LATER DATE UPON THE ARRIVAL OF THE CORRECT ALLOGRAFT FROM THE TISSUE CENTER. NO LASTING EFFECTS OR COMPLICATION FROM EITHER SURGERY. TISSUE CENTER AND VENDOR ADVISED ON DATE OF EVENT OF PACKAGING AND CONTENTS ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOPERSERVED LEFT FOREARM RADIUS BONE HUMAN BONE ALLOGRAFT LMO NORTHWEST TISSUE CENTER RADIUS LEFT FOREARM *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization