BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD BASE UNIT

    MDR report key: 5547810 · Received August 23, 2004

    Report

    Report Number
    3004608878-2004-00009
    Event Type
    Other
    Date Received
    August 23, 2004
    Report Date
    August 11, 2004
    Manufacturer
    SCHAERER MAYFIELD USA, INC.
    Product Code
    FSM
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS RECEIVED BY INTEGRA ON 07/28/2004 AND EVALUATED. THE FOLLOWING INFO IS A SUMMARY OF THE EVALUATION AND CONCLUSION RESULTS: EVALUATION: THE DEVICE WAS RECEIVED WITH THE ADJUSTMENT WRENCH MISSING, THE LOCK HANDLE OUT OF ADJUSTMENT, AND IN NEED OF GENERAL MAINTENANCE. THE DEVICE WAS FUNCTIONALLY TESTED AND WHEN PRESSURE WAS APPLIED TO THE DEVICE, THE LOCK HANDLE SLIPPED. THE LOCK HANDLE WAS ADJUSTED TO THE PROPER ADJUSTMENT, AND PRESSURE WAS APPLIED. THE DEVICE HELD THE CORRECT AMOUNT OF PRESSURE AND PERFORMED PROPERLY. CONCLUSION: BASED ON THE NATURE OF THE PROBLEM, INFO FROM THE CUSTOMER, AND INTEGRA'S EVALUATION RESULTS, IT IS CONCLUDED THAT THE DEVICE MOST LIKELY SLIPPED BECAUSE THE LOCK HANDLE WAS NOT PROPERLY ADJUSTED. NO DIRECT CONCLUSION COULD BE DETERMINED AS TO HOW OR WHEN THE DEVICE BECAME OUT OF ADJUSTMENT. HOWEVER, THE MAYFIELD BASE UNIT INSTRUCTION MANUAL DOES NOTE THAT "IT IS IMPORTANT TO PERIODICALLY ADJUST THE TENSION OF THE LOCKING LEVER TO COMPENSATE FOR CHANGES WHICH OCCUR WITH NORMAL USE". CORRECTIVE ACTION: NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME, HOWEVER AS AN AID TO THE NEURO-SURGERY STAFF, INTEGRA WILL SEND A COPY OF THE CD "MAYFIELD PROPER SKULL CLAMP POSITIONING". THE STAFF SHOULD FIND THIS HELPFUL.

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO POSITION HEAD FOR CERVICAL SURGERY, HEAD KEPT SAGGING FORWARD. APPROX IMATELY ON THE THIRD ATTEMPT TO POSITION, THE PHYSICIAN APPLIED PRESSURE/TORQUE TO POSITION HEAD, THE HEAD SLIPPED WITH PINS TEARING SCALP AS THEY CAME FREE. THE PATIENT SUSTAINED A ONE INCH LACERATION OF THE LEFT TEMPORAL SCALP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD BASE UNIT BASE UNIT FSM SCHAERER MAYFIELD USA, INC. 4-0-A-2001 1991

    Patients

    Seq Age Sex Outcome Treatment
    1 Other