BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRS RETRACTOR ARM

    MDR report key: 4340465 · Received December 15, 2014

    Report

    Report Number
    3004608878-2014-00241
    Event Type
    Malfunction
    Date Received
    December 15, 2014
    Report Date
    November 17, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    GZT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS EXPECTED TO BE RETURNED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    LINK BODY WAS DAMAGED. THERE WAS NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820733 BRS RETRACTOR ARM BRAIN RETRACTOR SYSTEM GZT INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1