BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD BASE UNIT

    MDR report key: 982449 · Received January 18, 2008

    Report

    Report Number
    3004608878-2008-00002
    Event Type
    Malfunction
    Date Received
    January 18, 2008
    Date of Event
    July 17, 2007
    Report Date
    January 18, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INCIDENT. CORRESPONDENCE SHOULD BE SENT TO: INTEGRA LIFESCIENCES CORPORATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE POSITIONING OF A PT'S HEAD INTO THE SKULL CLAMP, THE HANDLE OF THE BASE UNIT ASSEMBLY BROKE. THERE WAS NO PT INJURY REPORTED. THIS REPORTED INCIDENT IS LINKED TO MEDWATCH 3004608878-2008-00003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD BASE UNIT BASE UNIT HBL INTEGRA LIFESCIENCES CORPORATION 031

    Patients

    Seq Age Sex Outcome Treatment
    1