BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 2842146 · Received November 13, 2012

    Report

    Report Number
    3004608878-2012-00211
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 13, 2012
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN REC'D FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A MAYFIELD SKULL CLAMP WAS INVOLVED IN A SLIPPAGE WHICH WAS DESCRIBED AS FOLLOWS, "DOCTORS HAD PINNED PTS' HEAD (PT WAS FACE DOWN ON BED) FOR A SPINE PROCEDURE WHEN THEY WANTED TO RE ADJUST PTS' HEAD HAD SLIPPED. A LACERATION OCCURRED WHICH THEY STAPLED. NO DEATH ALLEGED. DOCTORS ASKED FOR ANOTHER CLAMP WITH MAYFIELD PINS AND RE CLAMPED THE PT. ALL WAS FINE WITH CLAMP, BUT THEN DOCTORS DECIDED TO CANCEL SURGERY ANYWAY."

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention