BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRS RETRACTOR ARM

    MDR report key: 4347449 · Received December 12, 2014

    Report

    Report Number
    3004608878-2014-00242
    Event Type
    Malfunction
    Date Received
    December 12, 2014
    Report Date
    November 17, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    GZT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNK IF THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS EXPECTED TO BE RETURNED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A LOCK SYSTEM FAILURE WAS REPORTED. THERE WAS NO PT IMPACT. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808235 BRS RETRACTOR ARM BRAIN RETRACTOR SYSTEM GZT INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1