BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 2930347 · Received January 22, 2013

    Report

    Report Number
    3004608878-2013-00015
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 21, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    A CRANIOTOMY WAS BEING PERFORMED ON (B)(6) 2013, WHEN THE MAYFIELD SKULL CLAMP SLIPPED AND CAUSED A SMALL LACERATION. THE WOUND DID NOT REQUIRE ANY SUTURING OR STAPLING. THE PATIENT RECOVERED AND WAS DISCHARGED ON (B)(6) 2013. IT IS UNKNOWN WHETHER THE PATIENT WAS REPOSITIONED DURING THE SURGERY. IT WAS THOUGHT BUT, HAS NOT BEEN CONFIRMED, THAT THE UNIT WAS SET AT 60 POUNDS OF PRESSURE BUT DROPPED TO 20 DURING THE PROCEDURE. THE MANAGER WAS UNABLE TO PROVIDE ANY FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30988 MAYFIELD MODIFIED SKULL CLAMP NONE HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1