BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1883064 · Received October 15, 2010

    Report

    Report Number
    3004608878-2010-00105
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 26, 2010
    Report Date
    October 15, 2010
    Manufacturer
    INTEGRA-OHIO, INC.
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED ON (B)(6), 2010 THAT THE TORQUE SCREW WAS NOT WORKING PROPERLY AND THERE WAS NO PT CONTACT. ADDITIONAL INFO WAS RECEIVED FROM THE CUSTOMER ON (B)(6), 2010 THAT THE 80 PSI TORQUE SCREW DID NOT FUNCTION PROPERLY. THE PRODUCT PROBLEM WAS DISCOVERED WHEN THE SURGEON WAS PUTTING IT ON THE PT'S HEAD. THERE WAS NO PT INJURY. IT CAUSED ABOUT A 10 MINUTE DELAY. THEY HAD TO GET ANOTHER SKULL CLAMP. ADDITIONAL CLINICAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA-OHIO, INC. 077

    Patients

    Seq Age Sex Outcome Treatment
    1