BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 1912010 · Received December 1, 2010

    Report

    Report Number
    1063481-2010-00055
    Event Type
    Injury
    Date Received
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MUQ
    PMA / PMN Number
    P010003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CRYOLIFE IS OBTAINING A COPY OF THE FULL ARTICLE AND AN INVESTIGATION HAS BEEN INITIATED.

    Description of Event or Problem · 1

    ACCORDING TO A JOURNAL ARTICLE (NEUROSURGERY QUARTERLY: DECEMBER 2010 - VOLUME 20 - ISSUE 4 - P253-255) ABSTRACT ENTITLED "ACUTE MASS FORMATION OF BIOGLUE AFTER SPINAL DURAL REPAIR: A GLUE-OMA CASE REPORT", THE PATIENT UNDERWENT SURGERY FOR L5-S1 DISC HERNIATION. BIOGLUE WAS APPLIED TO REINFORCE THE REPAIR OF AN INTRAOPERATIVE DURAL TEAR. A WORSENING OF SCIATICA IN THE IMMEDIATE POSTOPERATIVE PERIOD WAS REPORTEDLY OBSERVED. AN MRI PERFORMED ON POSTOPERATIVE DAY 2 SHOWED A MASS LESION IN THE SITE OF THE SURGERY. REOPERATION WAS PERFORMED AND A MASS OF BIOGLUE COMPRESSING THE NERVE ROOTS WAS RESECTED. ACCORDING TO THE REPORT, THE PATIENT'S COMPLAINTS COMPLETELY RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOGLUE SURGICAL ADHESIVE SURGICAL ADHESIVE MUQ CRYOLIFE, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention