BEUDAMED
    FDA Adverse Event Summary report: N

    MAYFIELD

    MDR report key: 1211943 · Received September 12, 2008

    Report

    Report Number
    1211943
    Date Received
    September 12, 2008
    Date of Event
    July 9, 2008
    Report Date
    September 10, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT SCHEDULED FOR POSTERIOR CERVICAL FUSION. AT THE END OF THE PROCEDURE, IT WAS NOTED THAT THE PIN SITES ON THE HEAD HAD SHIFTED. THE LEFT POSTERIOR PIN SITE HAD A ONE INCH TEAR. THE LACERATION WAS SUTURED BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD CLAMP, SKULL HBL INTEGRA LIFESCIENCES CORPORATION 40A1059 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR