BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT CONTAINING CC1.P1 AND THE IP1 INTRODUCER

    MDR report key: 2182261 · Received July 12, 2011

    Report

    Report Number
    9617494-2011-00003
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    INTEGRA, MIELKENDORF
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A LICOX (KIT CONTAINING CC1.P1 AND THE IP1 INTRODUCER) BOLT WAS IN PLACE FOR SEVERAL DAYS WHEN IT BECAME LOOSE AND WAS REMOVED. ADD'L INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIT CONTAINING CC1.P1 AND THE IP1 INTRODUCER NA GWM INTEGRA, MIELKENDORF 110211

    Patients

    Seq Age Sex Outcome Treatment
    1