BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD HEAD HOLDER

    MDR report key: 2902974 · Received December 26, 2012

    Report

    Report Number
    3004608878-2012-00241
    Event Type
    Injury
    Date Received
    December 26, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 26, 2012
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS EXPECTED TO BE RETURNED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO INTEGRA "MD PLACED SKULL PINS IN MAYFIELD HEADREST; UPON TURNING PATIENT TO PRONE POSITION, HEADREST SHIFTED AND PIN CAUSED LACERATION ON PATIENT'S SKULL. THE HEADREST WAS IMMEDIATELY REMOVED FROM CASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD HEAD HOLDER SKULLCLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R