BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRA CAMINO

    MDR report key: 841427 · Received April 23, 2007

    Report

    Report Number
    841427
    Event Type
    Injury
    Date Received
    April 23, 2007
    Date of Event
    April 11, 2007
    Report Date
    April 20, 2007
    Manufacturer
    INTEGRA LIFE SCIENCES
    Product Code
    GWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INTRA CRANIAL PRESSURE MONITOR BOLT APPEARED TO BE LEANING AND BEGAN LOSING WAVEFORM. THE BOLT AND WIRE WERE STILL INTACT, YET, BOWED AT THE SCALP. PT. WAS RETURNED TO SURGERY TO REMOVE BROKEN BOLT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRA CAMINO OLM INTRACRANIAL PRESSURE MONITORING KIT GWM INTEGRA LIFE SCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention