BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD

    MDR report key: 1003937 · Received January 29, 2008

    Report

    Report Number
    1003937
    Event Type
    Malfunction
    Date Received
    January 29, 2008
    Date of Event
    December 31, 2007
    Report Date
    January 29, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SKULL CLAMP PLACED BY A RESIDENT INTRA-OPERATIVELY CAUSED A LACERATION OF THE SKULL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD SKULL CLAMP HBL INTEGRA LIFESCIENCES CORPORATION 40A1059 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR