BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD INFINITY SKULL CLAMP

    MDR report key: 1854215 · Received September 3, 2010

    Report

    Report Number
    3004608878-2010-00092
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 11, 2010
    Report Date
    September 3, 2010
    Manufacturer
    INTEGRA-OHIO
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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

    THE SALES REPRESENTATIVE REPORTED THAT THE PRODUCT PROBLEM WAS A LOCKING ISSUE. THE LOCK WOULD NOT UNLOCK WHEN THE SURGEON TRIED TO ADJUST THE MAYFIELD INFINITY SKULL CLAMP. WHEN THE SURGEON WAS ABLE TO UNLOCK IT AND ADJUST THE CLAMP, HE COULD NOT LOCK IT BACK. THIS PROBLEM TOOK ABOUT 30 MINUTES. THE SKULL PINS HAD TO BE REMOVED AND ANOTHER KIND OF SKULL CLAMP (MAYFIELD MODIFIED SKULL CLAMP (B)(4)) WAS USED. THE TYPE OF PROCEDURE WAS A CRANIOPLASTY. NO PATIENT INJURY OCCURRED. INTEGRA ADULT DISPOSABLE PINS WERE USED. NO STEREOTAXY DEVICE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD INFINITY SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA-OHIO 104

    Patients

    Seq Age Sex Outcome Treatment
    1