BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 2896808 · Received December 28, 2012

    Report

    Report Number
    3004608878-2012-00245
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    December 12, 2012
    Report Date
    December 28, 2012
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INTEGRA LIFESCIENCES RECEIVED A REPORT REGARDING A MAYFIELD MODIFIED SKULL CLAMP WHICH WAS DESCRIBED AS, "IT IS TOO LOOSE BETWEEN THE PISTON AND THE PAWL ARM EVEN IF THE DEVICE IS FIXED ON THE PATIENT. THE PISTON SPRING IS WORN." THE EVENT LED TO AN INCREASE OF THE SURGERY TIME BY 30 MINUTES. THERE WAS NO PATIENT INJURY OR DEATH INVOLVED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1