BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD SKULL CLAMP

    MDR report key: 908176 · Received October 9, 2004

    Report

    Report Number
    3004608878-2004-00015
    Event Type
    Other
    Date Received
    October 9, 2004
    Manufacturer
    *
    Product Code
    HBL
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON 09/09/2004, INTEGRA LIFESCIENCES CORP. (INTEGRA) WAS NOTIFIED BY A CUSTOMER REP AT HOSPITAL OF AN INCIDENT IN WHICH THE SUSPECT SKULL CLAMP WAS BEING USED AND THERE WAS PT INJURY (LACERATION). THE CUSTOMER REQUESTED A TRADE IN OF THE SUSPECT CLAMP FOR "CREDIT" ON A NEW SKULL CALMP. THE SUSPECT DEVICE WAS RETURNED FROM HOSPITAL TO INTEGRA LIFESCIENCES CORPORATION (INTEGRA) ON 09/15/2004 AND EVALUATED. THE FINDINGS ARE LISTED BELOW: EVALUATION: THE SUSPECT DEVICE WAS MANUFACTURED IN 1989, WAS NOT A 19-1042 SKULL CLAMP AS REPORTED BY THE HOSPITAL, BUT WAS A 40A1059 SKULL CLAMP. THE 80 POUND TORQUE KNOB TESTED GOOD ON PRESSURE. THE SWIVEL BASE DID HAVE SOME ROTATIONAL MOVEMENT IN THE LOCKED POSITION, BUT THIS WOULD NOT HAVE CAUSED A PROBLEM WHICH WOULD CAUSE A LACERATION. CONCLUSION: BASED ON THE NATURE OF THE PROBLEM, INFORMATION REPORTED FROM THE CUSTOMER, AND INTEGRA'S EVALUATION RESULTS OF THE SUSPECT DEVICE, NO CONCLUSION COULD BE DETERMINED AS TO HOW OR WHY THE PATIENT RECEIVED A LACERATION. CORRECTIVE ACTION: NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. HOWEVER, AS AN AID TO THE NEURO-SURGERY STAFF AT HOSPITAL, 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

    AT OF THE TIME OF THIS REPORT, THE ONLY INFORMATION OBTAINED FROM THE REPORTER IS THAT THE PT SUSTAINED A SCALP LACERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD SKULL CLAMP SKULL CLAMP HBL * A-1059 894

    Patients

    Seq Age Sex Outcome Treatment
    1 *