BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1041342 · Received May 8, 2008

    Report

    Report Number
    3003418325-2008-00008
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    April 17, 2008
    Report Date
    May 6, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAYFIELD (B) (4) UNIT WAS RECEIVED AND EVALUATED BY THE MANUFACTURER. THE UNIT WAS PUT UNDER PRESSURE AND THE SLIPPAGE CONDITION COULD NOT BE DUPLICATED. THE 80# TORQUE KNOB TESTED GOOD UNDER PRESSURE AND THE RATCHET EXTENSION ARM HAD NO VISIBLE CRACKS. THE LOCK HAD A LITTLE ROTATIONAL MOVEMENT. THE LARGE STARBURST TEETH SHOWED SOME WEAR BUT WERE STILL FUNCTIONAL. THE ROCKER ARM PASSES GO NO-GO GAGE AND ALL OTHER COMPONENTS ARE FUNCTIONAL. GENERAL MAINTENANCE AND CLEANING WERE REQUIRED. ALTHOUGH THE HOSPITAL HAS INDICATED THAT THEY PREVIOUSLY RETURNED THIS EQUIPMENT FOR REPAIR ON 6/11/07, THE MFR'S REPAIR RECORDS CANNOT CONFIRM THIS HAVING OCCURRED.

    Description of Event or Problem · 1

    THE USER FACILITY INITIALLY REPORTED THAT THE PT'S HEAD MOVED DURING A CERVICAL LAMINECTOMY AND NO PT INJURY WAS REPORTED. ADD'L INFO WAS REPORTED ON 4/17/08 CONFIRMING THAT THE PT HAD SUSTAINED A THREE INCH LACERATION TO THE LEFT SIDE OF THE HEAD WHEN THE DISPOSABLE PIN BECAME LOOSE AND THE PT'S HEAD SLID DOWN DURING THE SURGICAL PROCEDURE. THE PT HAD AN INTRA-OPERATIVE PLASTIC SURGERY CONSULT AND THE THREE INCH LACERATION WAS CLOSED BEFORE THE PT LEFT THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD MODIFIED SKULL CLAMP MAYFIELD CLAMP HBL INTEGRA LIFESCIENCES CORPORATION 051

    Patients

    Seq Age Sex Outcome Treatment
    1