BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1943819 · Received December 21, 2010

    Report

    Report Number
    3004608878-2010-00145
    Event Type
    Other
    Date Received
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    INTEGRA OHIO
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A THOROUGH INVESTIGATION OF THE RETURNED PRODUCT FOUND THAT THE PRODUCT MET FUNCTIONAL SPECIFICATIONS. THE ROOT CAUSE OF THE SLIPPAGE OBSERVED WAS NOT RELATED TO THE MFR OR DESIGN OF THE DEVICE. INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED A COMPLAINT ABOUT A MAYFIELD SKULL CLAMP WHICH WAS DESCRIBED IN THE FOLLOWING MANNER, "THERE WAS A PROBLEM WITH THE TORQUE SCREW ON THE DEVICE. IT DID NOT HOLD THE TORQUE ALLOWING THE DEVICE TO LOOSEN AND SLIP CAUSING THE LACERATION". IT WAS ALSO REPORTED THAT THE HOSPITAL WAS USING THE INTEGRA (B)(4) ADAPTOR ON (B)(4) WITH A DURO BASE UNIT DURING THE PROCEDURE. INFO REGARDING PT DEMOGRAPHICS, TYPE OF PROCEDURE AND EVENT DATE WAS NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1