BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1170245 · Received September 10, 2008

    Report

    Report Number
    3004608878-2008-00073
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Report Date
    September 10, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTS THAT THEIR WAS A PATIENT LACERATION WHEN THE CLAMP SLIPPED ON A PATIENT. ADDITIONAL INFORMATION: THE NURSE MANAGER REPORTED VIA TELEPHONE CONVERSATION THAT DURING THE POSTERIOR APPROACH TO THE ANTERIOR/POSTERIOR CERVICAL FUSION THE SURGEON NOTICED THAT THE PATIENT'S HEAD MOVED. A LACERATION WAS NOTED NEAR THE LEFT EYE, NO SUTURES WERE REQUIRED. THIS INCIDENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD MODIFIED SKULL CLAMP MAYFIELD CLAMP HBL INTEGRA LIFESCIENCES CORPORATION 084

    Patients

    Seq Age Sex Outcome Treatment
    1