BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASEAL EXACT SPINE SEALANT SYSTEM 5ML US BOX OF

    MDR report key: 4944956 · Received July 24, 2015

    Report

    Report Number
    3003418325-2015-00014
    Event Type
    Injury
    Date Received
    July 24, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 30, 2015
    Manufacturer
    INTEGRA LIFESCIENCES HOLDING ION
    Product Code
    NQR
    PMA / PMN Number
    P080013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA COMPLETED ITS INTERNAL INVESTIGATION 8/27/2015. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN PERFORMED. THIS REVIEW CONFIRMED THAT THIS LOT OF PRODUCT WAS REVIEWED AND RELEASED ACCORDING TO QA SPECIFICATIONS. A REVIEW OF HISTORICAL COMPLAINT DATA DISPLAYED NO INCREASE IN TRENDS. THE CLINICALLY APPLIED PRODUCT WAS NOT RETURNED FOR EVALUATION; THEREFORE, WE ARE UNABLE TO IDENTIFY THE SPECIFIC CAUSE FOR THE PROBLEM REPORTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    (B)(4) STUDY. ON (B)(6) 2015, A (B)(6) WHITE MALE PT UNDERWENT A SPINAL FUSION (C3-C6) FOR CERVICAL SPONDYLOSIS. THE PT DID NOT REPORT A HISTORY OF A PREVIOUS SPINAL OR NEUROLOGICAL SURGERY. THE PT DID NOT HAVE ANY RISK FACTORS FOR A DUROTOMY. A VALSALVA MANEUVER WAS NOT PERFORMED AT BASELINE. DURING THE SURGERY, AN INCIDENTAL DURAL TEAR (LENGTH OF DURAL INCISION: UNK) OCCURRED WHICH REQUIRED REPAIR. THE DURAL TEAR WAS REPAIRED USING DURASEAL EXACT. THE PT HAD CEREBROSPINAL FLUID (CSF) LEAK DURING THE INITIAL SURGERY AND IT WAS REPAIRED, OPERATING NOTES CONFIRMS THERE WAS NO MORE LEAK. SUTURES WERE USED FOR CLOSING THE MAIN WOUND. THE NEXT MORNING THE DRAIN THAT WAS PLACED DURING SURGERY WAS INADVERTENTLY REMOVED AND CSF WAS NOTE D TO BE IN THE DRAIN. THE PT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) ON (B)(6) 2015. THE EVENT WAS CLASSIFIED AS A SERIOUS ADVERSE EVENT. THE RELATIONSHIP TO THE DEVICE WAS RECORDED AS "POSSIBLE". THE PT HAD NO UNDERLYING CONDITIONS/MEDICAL HISTORY RELEVANT TO THE EVENT. AT THE TIME OF THE REPORT, NEUROLOGICAL EXAM WAS NOT RECORDED. THE PT HAD PROLONGED HOSPITALIZATION IN THE ICU. THE EVENT WAS CONSIDERED RESOLVED ON 06/22/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482416 DURASEAL EXACT SPINE SEALANT SYSTEM 5ML US BOX OF DURASEAL SPINE NQR INTEGRA LIFESCIENCES HOLDING ION N5A0949X

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| O DURAPLASTY MATERIAL (ONLAY)