BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 8026069 · Received October 31, 2018

    Report

    Report Number
    2210968-2018-76866
    Event Type
    Injury
    Date Received
    October 31, 2018
    Report Date
    October 16, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: NEUROSURGERY. 2011; 68(1): 57¿63. DOI: 10.1227/NEU.0B013E318208F181. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE : SURGICAL TECHNIQUE AND OUTCOMES IN THE TREATMENT OF SPINAL CORD EPENDYMOMAS, PART 1: INTRAMEDULLARY EPENDYMOMAS" AUTHOR: ELISA J. KUCIA, MD, NICHOLAS C. BAMBAKIDIS, MD, STEVE W. CHANG, MD* ROBERT F. SPETZLER, MD. CITATION: NEUROSURGERY. 2011; 68(1): 57¿63. DOI: 10.1227/NEU.0B013E318208F181. INTRAMEDULLARY SPINAL EPENDYMOMAS ARE RARE TUMORS. THE OBJECTIVES OF THE STUDY WAS TO PROVIDE A LARGE RETROSPECTIVE REVIEW IN THE MODERN NEURO-IMAGING ERA FROM A TERTIARY CENTER WHERE AGGRESSIVE SURGICAL RESECTION IS FAVORED. A TOTAL OF 67 CASES (45 MALE AND 22 FEMALE PATIENTS; AGE RANGE: 11 TO 78 YEARS OLD) UNDERWENT RESECTION OF A SPINAL CORD EPENDYMOMA FROM JANUARY 1983 TO MAY 2006. THEIR CHARTS WERE REVIEWED RETROSPECTIVELY FOR AGE, GENDER, TUMOR LOCATION, SYMPTOMS AT DIAGNOSIS, DURATION OF SYMPTOMS BEFORE DIAGNOSIS, AND TREATMENT BEFORE PRESENTATION AT THE BARROW NEUROLOGICAL INSTITUTE. DURING THE SURGICAL PROCEDURE, THE DURA WAS OPENED IN THE MIDLINE WITH A NO. 15 SCALPEL BLADE AND TACKED AWAY FROM THE SPINAL CORD WITH NUROLON 4-0 STITCHES (ETHICON). THE DURA WAS CLOSED WITH A PROLENE 5-0 RUNNING STITCH (ETHICON). REPORTED POST-OPERATIVE COMPLICATIONS INCLUDED POST-OPERATIVE WOUND INFECTIONS (N-6) WHICH REQUIRED ANTIBIOTICS AND WOUND DEBRIDEMENT WHEN NEEDED, CEREBROSPINAL FLUID LEAK OR PSEUDOMENINGOCELE (N-9) WHICH REQUIRED MULTIPLE PROCEDURES FOR RESECTION OF THEIR LESIONS IN 4 PATIENTS AND LUMBAR DRAINAGE, WOUND REVISION, AND LUMBO-PERITONEAL SHUNTING WHEN NECESSARY, TETHERED SPINAL CORD (N-2), AND POST-OPERATIVE HEMATOMA (N-1) WHICH REQUIRED EMERGENT EVACUATION OF THE HEMATOMA. INTRAMEDULLARY SPINAL CORD EPENDYMOMAS ARE BEST TREATED BEFORE MAJOR NEUROLOGICAL DEFICITS APPEAR, WITH GTR BEING THE PRIMARY AIM OF TREATMENT. PREOPERATIVE NEUROLOGICAL STATUS REMAINS THE BEST PREDICTOR OF POSTOPERATIVE FUNCTION. THE USE OF ADJUVANT RADIOTHERAPY IS AN OPTION WHEN GTR CANNOT BE ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863612 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention