BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 4252983 · Received November 12, 2014

    Report

    Report Number
    3004608878-2014-00201
    Event Type
    Injury
    Date Received
    November 12, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 16, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    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 INFO.

    Description of Event or Problem · 1

    THE CLAMP SLIPPED AND CAUSED A 3/4 INCH LACERATION TO THE PATIENT. ADDITIONAL INFO WAS RECEIVED FROM THE CUSTOMER ON (B)(6) 2014 WITH THE FOLLOWING: ON (B)(6) 2014, A (B)(6) PATIENT WHO WAS HAVING A POSTERIOR CERVICAL WOUND EXPLORATION WAS POSITIONED PRONE FOR THE SURGERY. THE SURGERY WAS NOT PERFORMED WITH A STEREOTAXY DEVICE. WHEN THE MAYFIELD HEAD HOLDER WAS ATTACHED TO THE BASE, THERE WAS A MOVEMENT OF THE HEAD NOTED BY THE SURGEON. THE SURGEON SUPPORTED THE PATIENT'S HEAD AND HOLDER. THE HOLDER WAS REPLACED WITH A DIFFERENT HOLDER AND PIN SET. UPON EXAMINATION, A LACERATION OF APPROXIMATELY 3/4 OF AN INCH WAS NOTED ON THE PATIENT'S LEFT SCALP. PRESSURE WAS HELD TO THE SITE AND NO DRESSING WAS APPLIED. INTEGRA ADULT DISPOSABLE MAYFIELD PINS (A1072) WERE USED. THE CUSTOMER DID NOT HAVE THE PINS TO RETURN FOR EVALUATION NOR DID NOT HAVE THE LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729032 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION 137

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other