BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 4261985 · Received November 17, 2014

    Report

    Report Number
    4261985
    Date Received
    November 17, 2014
    Date of Event
    November 11, 2014
    Report Date
    November 17, 2014
    Manufacturer
    AESCULAP IMPLANT SYSTEMS, LLC
    Product Code
    HWA
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MALLOT BROKE DURING CASE. IT WAS NOT BROKEN IN THE PATIENT. IT WAS TAKEN OFF THE STERILE FIELD AND REPLACED WITH STERILE MALLOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743412 * IMPACTOR HWA AESCULAP IMPLANT SYSTEMS, LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR NO.