BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 2871663 · Received December 11, 2012

    Report

    Report Number
    3004608878-2012-00229
    Event Type
    Injury
    Date Received
    December 11, 2012
    Date of Event
    November 20, 2012
    Report Date
    December 11, 2012
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AN A1059 MAYFIELD MODIFIED SKULL CLAMP WAS INVOLVED IN AN EVENT WHICH WAS DESCRIBED AS FOLLOWS: A PATIENT WAS POSITIONED PRONE FOR A POSTERIOR CERVICAL LAMINECTOMY IN A MAYFIELD MODIFIED SKULL CLAMP. THE SURGEON PLACED THE MAYFIELD, WHICH WAS IN USE LESS THAN FIVE MINUTES, AND NOTED THAT IT WAS SLIDING. THE PATIENT'S POSITION HAD NOT CHANGED. THERE WAS A REVISION REQUIRED. SHE INCURRED A HEAD LACERATION OF THREE INCHES WHICH WAS SUTURED. THE SURGERY WAS DELAYED (LENGTH OF DELAY UNSPECIFIED) BECAUSE OF THE EVENT. MAYFIELD INTEGRA PINS REF: A1072 ADULT LOT 1122866 WERE USED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD MODIFIED SKULL CLAMP NONE HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention