BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNDT EXTERNAL W/NON-REINFORCED SEGMENT 3MM X 4M

    MDR report key: 6187494 · Received December 19, 2016

    Report

    Report Number
    2648988-2016-00059
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Report Date
    November 30, 2016
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    DWF
    PMA / PMN Number
    PRE-AMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT IN MIDDLE OF THERE WAS A DELAY IN SURGERY DUE TO THE NL8505076 SUNDT EXTERNAL WITH NON-REINFORCED SEGMENT PRODUCT NOT BEING DELIVERED. A PATIENT WAS PREPPED FOR SURGERY AND THERE WAS A DELAY IN THE SURGERY DUE TO THE INCIDENT. THE DEVICE WAS NOT IN CONTACT WITH A PATIENT AND THERE WAS NO PATIENT INJURY OR DEATH. THE SURGEON USED A DIFFERENT SIZE SUNDT AND FINISHED THE SURGERY. CSR DID NOT PLACE ORDER WHEN ORDER WAS SENT ¿ ALSO DID NOT SHIP OVERNIGHT AS REQUESTED BY THE PURCHASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838640 SUNDT EXTERNAL W/NON-REINFORCED SEGMENT 3MM X 4M N/A DWF INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1