BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACF/ML RETRACTORY BODY, TRANSVE

    MDR report key: 495067 · Received November 10, 2003

    Report

    Report Number
    1121308-2003-00041
    Event Type
    Malfunction
    Date Received
    November 10, 2003
    Report Date
    November 7, 2003
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    GZT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ONE OF THE ARMS ON THE INSTRUMENT IS BROKEN. THERE WAS PATIENT CONTACT BUT NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACF/ML RETRACTORY BODY, TRANSVE NON-POWERED SURGICAL INSTRUMENT GZT INTEGRA LIFESCIENCES CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *