BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD INFINITY XR2 SKULL CLAMP

    MDR report key: 2214068 · Received August 2, 2011

    Report

    Report Number
    3004608878-2011-00102
    Event Type
    Other
    Date Received
    August 2, 2011
    Date of Event
    June 28, 2011
    Report Date
    August 2, 2011
    Manufacturer
    INTEGRA, CINCINNATI
    Product Code
    HBL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 MAYFIELD INFINITY XR2 SKULL CLAMP WAS INVOLVED IN AN INCIDENT WHERE A PT INCURRED A SMALL LACERATION TO THEIR SCALP. THE EVENT WAS DESCRIBED AS FOLLOWS; A SURGEON PLACED THE SKULL CLAMP ON THE PT AND THE PT WAS PLACED PRONE ON AN OPEN JACKSON TABLE. ALL OF THE KNOBS WERE TIGHTENED AND SECURED. ABOUT TWO HOURS INTO THE POSTERIOR CERVICAL FUSION, THE SURGEON FELT A SLIGHT SLIP OF THE PT'S HEAD/NECK. THE KNOBS WERE CHECKED AND FOUND TO BE SECURE AND TIGHT. DURING THE INTEROPERATIVE FLUOROSCOPY, IT WAS NOTED THAT THE LANDMARKS HAD CHANGED FROM THE LAST IMAGE. THE SURGEON CONTINUED THE PROCEDURE AND UPON COMPLETION, A TWO INCH GASH WAS NOTED ON THE PT'S SKULL FROM ONE OF THE SKULL PINS THAT HAD SLIPPED AND LACERATED THE SKIN. THE LACERATION REQUIRED A FEW SUTURES. INTEGRA ADULT MAYFIELD TITANIUM SKULL PINS (REFERENCE NUMBER A1120, LOT NUMBER 1111389) WERE USED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD INFINITY XR2 SKULL CLAMP MAYFIELD HBL INTEGRA, CINCINNATI NONE PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1