BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODIFIED MAYFIELD SKULL CLAMP

    MDR report key: 2061438 · Received April 12, 2011

    Report

    Report Number
    2061438
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 8, 2011
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGEON PLACED THE PATIENT INTO THE MAYFIELD SKULL CLAMP WITH THREE POINT FIXATION. THE PATIENT WAS THEN TURNED FROM SUPINE TO PRONE POSITION. THE SURGEON THEN INSPECTED THE POSITIONING AND IT WAS NOTED THAT THE PINS HAD SLIPPED CREATING A LACERATION TO THE LEFT SIDE OF THE PATIENT'S SCALP APPROXIMATELY 3 INCHES LONG. STAPLES WERE USED TO CLOSE THE PATIENT'S LACERATION. THE SURGEON REAPPLIED THE SAME MAYFIELD SKULL CLAMP WITH THREE POINT FIXATION USING THE SAME PINS. AS THE PATIENT WAS REPOSITIONED PRONE AND THE PATIENT'S HEAD WAS INSPECTED A LACERATION WAS NOTED ON THE RIGHT SIDE APPROXIMATELY THREE INCHES LONG. THIS SCALP LACERATION WAS REPAIRED WITH STAPLES. THE SURGEON THEN POSITIONED THE PATIENT IN A DIFFERENT MAYFIELD SKULL CLAMP WITH THREE POINT FIXATION WITHOUT INCIDENT AND PROCEEDED WITH THE CASE. THE PINS WERE NOT RETAINED BY THE HOSPITAL STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODIFIED MAYFIELD SKULL CLAMP SKULL CLAMP SURGICAL DEVICE HBL INTEGRA LIFESCIENCES CORPORATION A-1059 *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other| R