BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 3023009 · Received March 21, 2013

    Report

    Report Number
    3004608878-2013-00049
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 21, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    AN A1059 WAS REPORTED AS FOLLOWS, "THE LOCKING MECHANISM OF THE DEVICE WAS TOO LOOSE AND OPENED DURING A CRANIOTOMY." NO INFORMATION REGARDING PATIENT IMPACT OR IF THERE WAS A SURGICAL DELAY WAS PROVIDED. THE PATIENT'S GENDER AND AGE WAS PROVIDED. 'SURGERY DELAY: UNKNOWN. WAS ANOTHER CLAMP USED TO FOLLOW THE SURGERY? NO, IT WAS NOT POSSIBLE AS IT WAS IN THE FINAL PHASE OF THE SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118459 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION 124

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR