BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD 2000 SKULL CLAMP

    MDR report key: 886671 · Received October 29, 2004

    Report

    Report Number
    1525725-2004-00017
    Event Type
    Other
    Date Received
    October 29, 2004
    Report Date
    September 30, 2004
    Manufacturer
    OHIO MEDICAL INSTRUMENT CO
    Product Code
    HBF
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS RETURNED TO INTEGRA LIFESCIENCES CORP ON OCTOBER 1, 2004 FOR EVAL AND REPAIR. THE FOLLOWING IS A SUMMARY OF THE EVAL AND CONCLUSION OF RESULTS. EVAL: THE 80 POUND TORQUE KNOB TESTED IN THE ACCEPTABLE RANGE AT 20, 40 60, AND 80 POUNDS. THE LARGE STARBURST NEEDED HELI-COIL TREAD REPLACEMENT BECAUSE OF CROSS-THREADING. THE SWIVEL LOCK WAS DIFFICULT TO LOCK AND UNLOCK DUE TO A HEAVY BUILD-UP ON THE INTERNAL COMPONENTS. THE CAUTION LABEL WAS DAMAGED FROM CLEANING AT ELEVATED TEMPERATURES WHICH MAY HAVE ALSO DAMAGED THE INTERNAL COMPONENTS. AS REC'D, THE UNIT WAS TESTED UNDER PRESSURE AND WAS DIFFICULT TO PROPERLY POSITION, ADJUST AND LOCK. CONCLUSION: BASED ON THE NATURE OF THE INQUIRY, INTEGRA LIFESCIENCES EVAL RESULTS AND REPORTED INFO, NO DEFINITE CONCLUSION COULD BE DETERMINED AS TO HOW OR WHY THE DEVICE REPORTEDLY SLIPPED RESULTING IN A SCALP LACERATION. CORRECTIVE ACTION: NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. HOWEVER, AS AN AID TO THE NEURO STAFF AT MED CTR, INTEGRA LIFESCIENCES 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 POSITIONING HEADREST, SWIVEL ON THE DOUBLE PIN SEEMED TIGHT. WHEN PRESSURE WAS USED TO MOVE IT, THE PIN MOVED AND CREATED A LACERATION ON SCALP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD 2000 SKULL CLAMP SKULL CLAMP HBF OHIO MEDICAL INSTRUMENT CO 4-O-A-2000 979

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other