BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1914388 · Received November 18, 2010

    Report

    Report Number
    3004608878-2010-00128
    Event Type
    Other
    Date Received
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    INTEGRA OHIO
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REPORTED INFO AND INVESTIGATION OF THE RETURNED PRODUCT, THE REPORTED CONDITION OF PRODUCT SLIPPAGE COULD NOT BE CONFIRMED OR DUPLICATED. THE RETURNED UNIT PASSED ALL FUNCTIONAL AND PERFORMANCE TESTING AS RECEIVED. THE ROOT CAUSE OF THIS INCIDENT IS NOT RELATED TO THE MFR OR THE DESIGN OF THE UNIT.

    Description of Event or Problem · 1

    ON THE LAST WEEK OF (B)(6) 2010, IT WAS REPORTED THAT THE PRODUCT WAS EXTREMELY LOOSE. THE UNIT SLIPPED ON THE PT AND CAUSED A LACERATION. ADDITIONAL CLINICAL INFO HAS BEEN REQUESTED BUT NO FURTHER INFO WAS 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