BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUROLON NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 7997017 · Received October 23, 2018

    Report

    Report Number
    2210968-2018-76710
    Event Type
    Injury
    Date Received
    October 23, 2018
    Report Date
    October 9, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: NEUROSURG FOCUS 39 (2): E12, 2015; DOI: 10.3171/2015.5.FOCUS15187. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "COMPARISON OF MINIMALLY INVASIVE TRANSSPINOUS AND OPEN APPROACHES FOR THORACOLUMBAR INTRADURAL-EXTRAMEDULLARY SPINAL TUMORS." AUTHORS: KUNAL P. RAYGOR, MD, KHOI D. THAN, MD, DEAN CHOU, MD, AND PRAVEEN V. MUMMANENI, MD. CITATION: NEUROSURG FOCUS 39 (2): E12, 2015; DOI: 10.3171/2015.5.FOCUS15187. THIS RETROSPECTIVE STUDY AIMED TO COMPARE SURGICAL CHARACTERISTICS AND CLINICAL OUTCOMES OF SURGERY IN PATIENTS UNDERGOING MINI-OPEN AND OPEN APPROACHES FOR INTRADURAL-EXTRAMEDULLARY TUMOR RESECTION. FROM 2007 TO 2014, 51 PATIENTS UNDERGOING INTRADURAL SPINAL TUMOR RESECTIONS WERE ALLOCATED INTO TWO GROUPS: MINIMALLY INVASIVE SURGERY (N=25; MEAN AGE OF 51.3±17.4 YEARS; N=48% WERE FEMALE) AND OPEN SURGERY (N=26; 51.7±15.9 YEARS; N=57.7% WERE FEMALE). IN THE PROCEDURE, DURA WAS CLOSED WITH A RUNNING 4-0 NUROLON SUTURE. "ON" BOTH GROUPS ADVERSE EVENTS INCLUDED PSEUDOMENINGOCELE (N=1), CEREBROSPINAL LEAKS (N=3) WHICH RESOLVED AFTER LUMBAR DRAIN PLACEMENT, SUBFASCIAL WOUND INFECTION (N=1) AND EPIDURAL HEMATOMA (N=1). THE EVENTS PSEUDOMENINGOCELE, SUBFASCIAL WOUND INFECTION AND EPIDURAL HEMATOMA EACH REQUIRED RETURN TO OPERATING ROOM. THE MINIMALLY INVASIVE TRANSSPINOUS APPROACH APPEARS TO BE SAFE AND EFFECTIVE AS THE OPEN TECHNIQUE, WITH ADVANTAGE OF SIGNIFICANTLY REDUCED INTRAOPERATIVE BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837211 NUROLON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention