BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD SWIVEL ADAPTOR

    MDR report key: 3832328 · Received February 10, 2014

    Report

    Report Number
    3004608878-2014-00011
    Event Type
    Malfunction
    Date Received
    February 10, 2014
    Date of Event
    January 14, 2014
    Report Date
    January 15, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 INFORMATION.

    Description of Event or Problem · 1

    THE NEUROSURGEON WAS PERFORMING A POSTERIOR CERVICAL CASE USING THE A2079 AND THE A2010. THE PATIENT WAS POSITIONED, DRAPED AND THE CASE HAD STARTED WHEN THE THREADED PIN OF THE SWIVEL ADAPTOR (A108) THAT CONNECTS TO THE A2010 SNAPPED CAUSING THE PATIENT'S HEAD TO FALL IN THE MIDDLE OF THE PROCEDURE. THE PATIENT HAD NEURO MONITORING DURING THE CASE AND AT THIS POINT OF THE DATE (B)(6) 2014, HAD NO DEFICITS. THE PATIENT IS STILL BEING OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87600 MAYFIELD SWIVEL ADAPTOR NONE HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1