BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD TRIAD SKULL CLAMP

    MDR report key: 2551630 · Received April 18, 2012

    Report

    Report Number
    3004608878-2012-00081
    Event Type
    Injury
    Date Received
    April 18, 2012
    Date of Event
    March 19, 2012
    Report Date
    April 18, 2012
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    MEDWATCH REPORT WITH UF/IMPORTER REPORT # (B)(4) WAS RECEIVED BY INTEGRA LIFESCIENCES CORP (B)(4) ON (B)(6) 2012. THE REPORTED EVENT WAS DESCRIBED AS THE PT'S HEAD MAY HAVE SLIPPED FROM THE MAYFIELD SKULL FIXATION DEVICE. THE MAYFIELD HEAD FIXATION DEVICE WAS ADJUSTED ON THE PT'S HEAD. BLEEDING WAS NOTED AT THE LACERATED PIN SITE. PRESSURE WAS APPLIED WITH GAUZE TO STOP THE BLEEDING. AFTER THE PROCEDURE WAS COMPLETED, THE PT WAS RETURNED TO SUPINE POSITION. THE LACERATION WAS INSPECTED AND CLOSED WITH STAPLES. ADD'L CLINICAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD TRIAD SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention