BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 4152480 · Received October 6, 2014

    Report

    Report Number
    3004608878-2014-00168
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Report Date
    September 10, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    DURING THE INSPECTION OF INCOMING GOODS BY THE DISTRIBUTER ON AN UNK DATE, IT WAS FOUND THAT THE MOVEMENT OF THE DEVICE WAS NOT SMOOTH AROUND 60 TO 80 POUNDS. THERE WAS NO PATIENT CONTACT OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622163 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION 141

    Patients

    Seq Age Sex Outcome Treatment
    1