BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 4173388 · Received October 10, 2014

    Report

    Report Number
    3004608878-2014-00180
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 19, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 INFORMATION.

    Description of Event or Problem · 1

    THIS IS THE FIRST REPORT OF TWO FROM THE SAME FACILITY INVOLVING AN A1059. (REFERENCE (B)(4)). RECENTLY PURCHASED A1059 MODIFIED SKULL CLAMPS APPEARED NOT TO RECEIVE MAYFIELD SKULL PIN AN A1083. THE INCIDENT WAS REPORTED BY TWO SEPARATE THEATRES THIS MORNING. IT APPEARS THAT THE SKULL PINS WHILST NOT "WOBBLY" THEY WERE LOOSE. REPORTED PROBLEMS OCCURRED WHILE THEY WERE SETTING UP, SO THE MAYFIELD EQUIPMENT WAS NOT ATTACHED TO ANY PATIENTS. THERE WERE NO PATIENT INJURIES AND THE INCREASE TO SURGERY TIME WAS ONLY ABOUT 5 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642700 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1