BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRA SNAP UNISYSTEM

    MDR report key: 606217 · Received May 18, 2005

    Report

    Report Number
    606217
    Event Type
    Injury
    Date Received
    May 18, 2005
    Date of Event
    May 11, 2005
    Report Date
    May 16, 2005
    Manufacturer
    INTEGRA LIFE SCIENCES
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH HYDROCEPHALUS, HAD INTEGRAL SHUNT SYSTEM PLACED IN 2004. PT DEVELOPED RECURRENT SYMPTOMS. THE INTEGRA SNAP UNISYSTEM WAS FRACTURED AT ITS CONNECTION TO THE VALVE WHEN MD RE-OPERATED ON PT IN 2005. SPILLING CSF INTO PT. THIS WAS A DEFECT IN THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRA SNAP UNISYSTEM STANDARD SHUNT JXG INTEGRA LIFE SCIENCES * 405865

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention