BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 3143000 · Received May 30, 2013

    Report

    Report Number
    3004608878-2013-00100
    Event Type
    Injury
    Date Received
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AN A1059 MAYFIELD SKULL CLAMP WAS REPORTED TO HAVE SLIPPED DURING A CRANIOTOMY. AS A RESULT THE PATIENT INCURRED A CUT ON HIS FOREHEAD WHICH REQUIRED SUTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238414 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention