BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1820095 · Received August 24, 2010

    Report

    Report Number
    3004608878-2010-00085
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 27, 2010
    Report Date
    August 24, 2010
    Manufacturer
    INTEGRA-OHIO, INC.
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS IS THE FIRST REPORT OF TWO THAT INVOLVED THE SAME PT, THE SAME SURGEON, FROM THE SAME FACILITY. (B)(4). ON (B)(6) 2010, AN (B)(6) FEMALE PT WAS UNDERGOING A POSTERIOR FOSSA CRANIOTOMY. THE MAYFIELD SKULL CLAMP WAS APPLIED WHEN THE PT WAS IN THE SUPINE POSITION. THE PT WAS TURNED TO A PRONE POSITION WHEN THE UNIT BECAME UNLOCKED. THE SURGEON HAD TO SECURE THE PT'S HEAD WITH HIS HANDS. ANOTHER DEVICE WAS APPLIED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. MAYFIELD PEDIATRIC DISPOSABLE PINS WERE BEING USED. THERE WAS NO STEREOTAXY DEVICE BEING USED DURING THIS PROCEDURE. THERE WAS NO INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA-OHIO, INC. 079

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR