BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 2850705 · Received November 20, 2012

    Report

    Report Number
    3004608878-2012-00219
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    September 5, 2012
    Report Date
    November 20, 2012
    Manufacturer
    INTEGRA LIFESCIENCES HOLDING CORPORATION OH/USA
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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

    A CERVICAL DECOMPRESSION FUSION WAS BEING PERFORMED WHILE UTILIZING AN A 1059 MAYFIELD SKULL CLAMP. THE PT WAS NOT REPOSITIONED DURING THE PROCEDURE. AN HOUR AND A HALF INTO THE PROCEDURE, THE ANESTHETIST LOOKED UNDER THE DRAPES AND NOTED THAT THE PT'S HEAD WAS NOT IN THE POSITION THE SURGEON PLACED IT IN PREOPERATIVELY. THE SURGEON BROKE SCRUB AND FOUND THAT THE MAYFIELD HAD SLIPPED, ALLOWING THE HEAD TO MOVE DOWNWARD TO THE MECHANICS OF THE HEADREST. THE EVENT RESULTED IN A PT LACERATION TO SIDE OF HER HEAD, WHICH REQUIRED CLOSURE WITH STAPLES. CODMAN DISPOSABLE ADULT SKULL PINS (CATALOG NUMBER 30-054) WERE USED DURING THIS PROCEDURE (LOT NUMBER UNK). THE SURGERY WAS NOT PERFORMED WITH A STEREOTAXY DEVICE. "THE PT OUTCOME WAS FINE."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention