BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DS3 SPINE 5ML US

    MDR report key: 3854914 · Received May 28, 2014

    Report

    Report Number
    1219930-2014-00369
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 21, 2014
    Report Date
    May 1, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    NQR
    PMA / PMN Number
    P040034
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAMINECTOMY. ACCORDING TO THE CLINICAL STUDY: SUMMARY OF EVENTS: SUBJECT 18-73 IS A (B)(6) CAUCASIAN MALE WITH A PAST MEDICAL HISTORY OF CHRONIC BACK PAIN AND RIGHT LOWER EXTREMITY LUMBAR RADICULOPATHY. THE SUBJECT HAS HAD THREE PREVIOUS SPINAL PROCEDURES: A LUMBAR LAMINECTOMIES IN 2003 AND 2013 AND A CERVICAL PROCEDURE IN 2005. ON (B)(6) 2014 THE SUBJECT UNDERWENT A DECOMPRESSIVE LUMBAR LAMINECTOMY FROM L3-L5 AT (B)(6) HOSPITAL IN WHICH AN INCIDENTAL CSF LEAK OCCURRED. THE AREA WAS SUTURED, DURAGEN WAS PLACED, AND THE AREA WAS SEALED WITH 3ML OF DURASEAL. ONCE A WATERTIGHT CLOSURE WAS OBTAINED, THE WOUND WAS THEN CLOSED WITH SUTURES AND STAPLES. ON POST-OP DAY 5 ((B)(6) 2014), THE SUBJECT PRESENTED AT THE ER WITH CLEAR DRAINAGE AT THE TOP OF THE SURGICAL INCISION AND POSITIONAL HEADACHE. SURGICAL I & D AND DURAL REPAIR WITH DURAGEN AND A FAT PATCH WAS PERFORMED ON (B)(6) 2014 FOR PERSISTENT SYMPTOMS. THE SUBJECT WAS DISCHARGED ON (B)(6) 2014. WHILE THE SUBJECT HAS NOT YET RETURNED FOR THEIR STUDY FOLLOW-UP, THE EVENT IS REPORTED TO BE RESOLVED AS OF (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315111 DS3 SPINE 5ML US DURASEAL SEALANT SYSTEM NQR COVIDIEN, FORMERLY US SURGICAL N4A1339X

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other