BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1551290 · Received November 24, 2009

    Report

    Report Number
    3004608878-2009-00087
    Event Type
    Malfunction
    Date Received
    November 24, 2009
    Report Date
    November 24, 2009
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION. THE RETURNED UNIT PASSES ALL REQUIRED FUNCTIONAL AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE MAY BE RELATED TO USER ERROR.

    Description of Event or Problem · 1

    A MAYFIELD SKULL CLAMP WAS INVOLVED IN A SLIPPAGE DURING A PATIENT PROCEDURE. THE REPORTER DESCRIBED THE INCIDENT AS, DURING THE PROCEDURE THE CLAMP SLIPPED. THE INCIDENT DID NOT CAUSE ANY INJURY TO THE PATIENT. THE NURSE REMINDS SURGEONS OF THE IMPORTANCE OF CHECKING THAT THE CORRECT PRESSURE IS EXERTED ON THE UNITS BEFORE PROCEDURES ARE BEGUN. SHE WILL CONTINUE TO RE-ENFORCE PRESSURE CHECKS PRIOR TO AND DURING SURGERY WITH PHYSICIANS. ADDITIONAL CLINICAL INFORMATION HAS BEEN REQUESTED, THE INTEGRA-LIFE SCIENCES MEDICAL AFFAIRS DEPARTMENT WANTS TO ENSURE THAT OUR PRODUCT IS BEING APPROPRIATELY APPLIED AND USED. THEREFORE, THE INTEGRA-LIFE SCIENCES SALES REPRESENTATIVE HAS BEEN INSTRUCTED TO PROVIDE IN-SERVICE TRAINING TO THE SURGEONS AND STAFF WHO USE MAYFIELD SKULL CLAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD MODIFIED SKULL CLAMP NA HBL

    Patients

    Seq Age Sex Outcome Treatment
    1