BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD 2000 RADOILUCENT CLAMP

    MDR report key: 2526511 · Received April 16, 2010

    Report

    Report Number
    2526511
    Event Type
    Malfunction
    Date Received
    April 16, 2010
    Date of Event
    January 14, 2010
    Report Date
    March 15, 2010
    Manufacturer
    INTEGRA LIFE SCIENCES
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BLEEDING AND LACERATION NOTED AFTER COMPLETION OF SURGERY, WHEN PINS WERE REMOVED. PROCEDURE: C6 -7 LAMINECTOMY WITH POSTERIOLATERAL FUSION WITH INSTRUMENTATION. LENGTH OF TIME IN USE BEFORE THE EVENT OCCURRED: 3 HOURS, 16 MINUTES. SKULL PINS USED: ADULT DISPOSABLE BY INTEGRA #(B)(4). PT POSITION: FROM SUPINE TO PRONE. RESULTED IN: SCALP LACERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD 2000 RADOILUCENT CLAMP SKULL CLAMP HBL INTEGRA LIFE SCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other