BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD

    MDR report key: 2957377 · Received October 16, 2004

    Report

    Report Number
    1525725-2004-00023
    Event Type
    Other
    Date Received
    October 16, 2004
    Manufacturer
    SCHAERER MAYFIELD USA, INC.
    Product Code
    HBL
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS RETURNED FROM (B)(6) TO INTEGRA LIFESCIENCES CORP ON (B)(4) 2004 AND EVALUATED. FURTHER REQUIRED INFORMATION WILL BE GIVEN WHEN MADE AVAILABLE BY THE REPORTER. THE FOLLOWING INFORMATION IS A SUMMARY OF THE EVALUATION AND CONCLUSION RESULTS: EVALUATION: THE 80 POIND TORQUE KNOB TESTED GOOD ON PRESSURES OF 20, 40, 60, AND 80 POUNDS. THE SWIVEL BASE DID HAVE LATERAL AND ROTATIONAL MOVEMENT IN THE LOCKED POSITION. WHEN THE DEVICE WAS PROPERLY POSITIONED, ADJUSTED AND LOCKED, INTEGRA LIFESCIENCES CORPORATION WAS NOT ABLE TO DUPLICATE THE ALLEGED SLIPPAGE CONDITION OR "PRESSURE SCREW DID NOT HOLD". THE DEVICE WAS IN NEED OF GENERAL MAINTENANCE DUE TO DAMAGE FROM REPEATED CLEANINGS AT POSSIBLE ELEVATED TEMPERATURES. THE CLEANING INSTRUCTIONS FOR THE A1059 SKULL CLAMP RECOMMENDED THAT AFTER EACH USE, THOROUGHLY CLEAN AND WIPE THE DEVICE WITH AN ANTISEPTIC SOLUTION AND DO NOT STEAM STERILIZE BECAUSE PLASTIC COMPONENTS WILL BE DAMAGED BY HEAT. THE DEVICE WAS IN NEED OF GENERAL MAINTENANCE AND WAS REPAIRED AND RETURNED TO (B)(6) ON (B)(4) 2004. CONCLUSION: BASED ON THE NATURE OF THE PROBLEM AND EVALUATION RESULTS OF INTEGRA LIFESCIENCES CORP, NO DIRECT CONCLUSION COULD BE DETERMINED AS TO HOW OR WHY THE DEVICE ALLEGEDLY SLIPPED RESULTING IN A PATIENT SCALP LACERATION. CORRECTIVE ACTION: NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. HOWEVER, AS AN AID TO THE NEURO-SURGERY STAFF AT (B)(6), INTEGRA LIFESCIENCES CORP WILL SEND A COPY OF THE CD "MAYFIELD PROPER SKULL CLAMP POSITIONING". THE STAFF SHOULD FIND THIS HELPFUL.

    Description of Event or Problem · 1

    AT THE TIME OF THIS REPORT, THE ONLY INFORMATION REPORTED BY (B)(6) IS THAT THE PRESSURE SCREW WAS NOT HOLDING CORRECTLY AND THE CLAMP SLIPPED WHILE ON THE PATIENT'S HEAD. THE PATIENT SUSTAINED A SCALP LACERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD SKULL CLAMP HBL SCHAERER MAYFIELD USA, INC. 4-0-A1059 904

    Patients

    Seq Age Sex Outcome Treatment
    1 Other