BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD 2000 RADIOLUCENT SKULL CLAMP

    MDR report key: 1812190 · Received August 17, 2010

    Report

    Report Number
    3004608878-2010-00080
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Report Date
    August 17, 2010
    Manufacturer
    INTEGRA - OHIO
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE UNIT WAS SLIPPING. NO PT INJURY. ADDITIONAL INFO WAS RECEIVED ON (B)(6), 2010 FROM THE CUSTOMER WITH THE FOLLOWING INFO: ON AN UNK DATE, AN ANEURYSM CLIPPING WAS BEING PERFORMED ON A PT. THE PT WAS POSITIONED IN A PRONE POSITION DURING SURGERY AND WAS NOT REPOSITIONED AT ANY TIME. IT WAS REPORTED THAT THE CUSTOMER NOTICED PLAY UPON PLACEMENT OF THE FIRST UNIT. IT WAS CHANGED TO A SECOND UNIT AND THE PT'S HEAD MOVED DURING THE INITIAL PERFORATION OF THE SKULL, ABOUT FIFTEEN MINUTES INTO THE SURGERY. THERE WAS A ROTATION OF THE TWO PIN SIDE WHEN LOCKED. NO REVISION WAS REQUIRED. THE EVENT DID NOT RESULT IN PT INJURY OR NEGATIVE OUTCOME. INTEGRA ADULT DISPOSABLE PINS (B)(4) WERE USED. LOT NUMBER OF THE PINS WERE UNK. NO STEREOTAXY DEVICE WAS USED. ADDITIONAL CLINICAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD 2000 RADIOLUCENT SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA - OHIO 057

    Patients

    Seq Age Sex Outcome Treatment
    1