BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1883020 · Received October 15, 2010

    Report

    Report Number
    3004608878-2010-00104
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    MAYFLED INTEGRA
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    (B)(4) MAYFIELD SKULL CLAMP WAS BEING USED DURING AN UNSPECIFIED PROCEDURE. THE EVENT WAS DESCRIBED AS FOLLOWS: THE SWIVEL LOCK DID NOT HOLD AND THE PT'S HEAD FELL. IT IS NOT KNOWN IF AN INJURY OCCURRED AS A RESULT. THE CLAMP WILL NOT BE RETURNED FOR AN INVESTIGATION. ADDITIONAL CLINICAL INFORMATION 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 MAYFLED INTEGRA

    Patients

    Seq Age Sex Outcome Treatment
    1