BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD ULTRA BASE UNIT

    MDR report key: 3881078 · Received April 7, 2014

    Report

    Report Number
    3004608878-2014-00036
    Event Type
    Malfunction
    Date Received
    April 7, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 21, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    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

    IT WAS REPORTED THAT THE DEVICE WAS INVOLVED IN AN INCIDENT MID PROCEDURE. ADD'L INFO WAS REQUESTED AND ON (B)(4) 2014, THE FOLLOWING WAS PROVIDED: ON (B)(6) 2014, A (B)(6) FEMALE UNDERWENT A CRANIOTOMY FOR HEMATOMA AND SKULL FRACTURE. IT WAS REPORTED THAT TWICE DURING THE PROCEDURE, THE MAYFIELD SEEM TO LOOSEN TO THE POINT THAT THE PT'S HEAD ALMOST SLIPPED OFF. A STAFF MEMBER HAD TO GO UNDER THE DRAPES TO READJUST IT. BOTH TIMES THE PT'S HEAD WAS ONLY ON THE HORSESHOE BY A COUPLE OF INCHES. THE GOLD LEVER THAT TIGHTENS THE JOINTS REMAINED LOCKED BOTH TIMES BUT AFTER THE SECOND READJUSTMENT, IT HAD TO BE TAPED SEVERAL TIMES TO SECURE IT TO THE FRAME. AFTER TAPING, THE PT'S HEAD WAS NO LONGER SLIDING OFF. THE LENGTH OF TIME THE PRODUCT WAS IN USE BEFORE THE EVENT OCCURRED WAS APPROXIMATELY ONE HOUR INTO THE PROCEDURE. THERE WAS NO PT INJURY. SURGERY DELAY WAS A TOTAL OF 15 TO 20 MINS (5 TO 10 MINS EACH TIME THE MAYFIELD WAS READJUSTED). THERE WAS NO PT ADVERSE CONSEQUENCE AS A RESULT OF THE SURGICAL DELAY. PT OUTCOME WAS REPORTED AS "NO ISSUES FROM THE MAYFIELD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206435 MAYFIELD ULTRA BASE UNIT BASE UNITS AND ADAPTERS FWZ INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR