BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 2794081 · Received October 11, 2012

    Report

    Report Number
    3004608878-2012-00182
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    September 17, 2012
    Report Date
    October 11, 2012
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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

    A 1059 MAYFIELD MODIFIED SKULL CLAMP WAS INVOLVED IN AN INCIDENT THAT CAUSED A PATIENT LACERATION. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012, AND WAS DESCRIBED AS FOLLOWS; A POSTERIOR CERVICAL DECOMPRESSIVE LAMINECTOMY WAS BEING PERFORMED WITH THE PATIENT POSITIONED PRONE FROM THE SUPINE POSITION. AFTER THE INITIAL MOVE TO THE PRONE POSITION AFTER INTUBATION BUT PRIOR TO SURGERY, AND AS THE MAYFIELD SKULL CLAMP WAS BEING CONNECTED TO THE HEADREST, THE SKULL CLAMP "SLIPPED." THE PATIENTS' HEAD POSITION/ALIGNMENT WAS CONSTANTLY MAINTAINED BY THE SURGEON. THE PATIENT WAS RETURNED TO THE SUPINE POSITION FOR EVALUATION AND THEN REPOSITIONED FOR THE PROCEDURE. THE SURGEON DESCRIBED THE MALFUNCTION AS "SLIPPED," IT DID NOT MAINTAIN PRESSURE AGAINST THE SKULL. THE SKULL CLAMP WAS APPLIED JUST MINUTES BEFORE INITIAL TURN TO PRONE POSITION AND "SLIPPED" BEFORE FINAL ATTACHMENT TO BED HEADREST ATTACHMENT WAS MADE. THE PATIENT INCURRED A SMALL LACERATION TO SCALP WHICH REQUIRED SKIN STAPLES TO CLOSE THE WOUND. THE LACERATION HEALED WITHOUT COMPLICATION. INTEGRA DISPOSABLE, ADULT SKULL PINS (A1072) LOT NUMBER 1122869 WERE USED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA 094

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention