BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD TRIAD SKULL CLAMP

    MDR report key: 4121266 · Received September 22, 2014

    Report

    Report Number
    3004608878-2014-00163
    Event Type
    Injury
    Date Received
    September 22, 2014
    Date of Event
    September 6, 2014
    Report Date
    August 28, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    AN EVENT OCCURRED INVOLVING AN A1108 TRIAD SKULL CLAMP. INITIALLY, IT WAS REPORTED THAT THE UNIT SLIPPED AND THERE WAS A LACERATION. THE EVENT WAS DESCRIBED AS FOLLOWS: A PT WAS ROTATED FROM SUPINE TO PRONE WITH THE MAYFIELD FOR A CRANIOTOMY AT 70 LBS OF PRESSURE AND THE SINGLE SIDE PIN SITE SLIPPED CAUSED A 3 CM LACERATION. THE LACERATION REQUIRED SUTURING. THE PT WAS REPOSITIONED AND LOCKED WITH THE SAME FRAME. NO FURTHER INCIDENT. PINS; INTEGRA MAYFIELD (B)(4). LOT 1140013 - PINS WERE DISPOSED OF. PT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587669 MAYFIELD TRIAD SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other