BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1880464 · Received October 11, 2010

    Report

    Report Number
    3004608878-2010-00103
    Event Type
    Other
    Date Received
    October 11, 2010
    Date of Event
    September 22, 2010
    Report Date
    October 11, 2010
    Manufacturer
    INTEGRA-OHIO
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    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

    AN INTEGRA SALES REPRESENTATIVE REPORTED THAT ON (B)(6), 2010, A FEMALE PT OF AN UNKNOWN AGE WAS TO UNDERGO SURGERY FOR A TUMOR REMOVAL. IT WAS REPORTED THAT THE PATIENT'S HEAD SLIPPED IN THE SKULL CLAMP. THE PT WAS REPOSITIONED AT SOMETIME DURING THE SURGERY TO PLACE THE CLAMP FURTHER FROM THE NASAL STRUCTURES. THE LENGTH OF TIME THE PRODUCT WAS IN USE BEFORE THE EVENT OCCURRED WAS APPROXIMATELY ONE HOUR. THE PT HAD A ONE INCH LACERATION THAT REQUIRED CLOSURE. THE SURGERY WAS STOPPED AND RESCHEDULED FOR (B)(6), 2010. MAYFIELD ADULT REUSABLE PINS (B)(4) WERE USED. THE PINS WERE NOT AVAILABLE FOR EVALUATION SINCE THEY WERE REPORTED TO BE MIXED IN WITH OTHER PINS. STEREOTAXY DEVICE WAS USED (MEDTRONIC STEALTHSTATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA-OHIO 019

    Patients

    Seq Age Sex Outcome Treatment
    1