BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUROLON NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 7984671 · Received October 19, 2018

    Report

    Report Number
    2210968-2018-76653
    Event Type
    Injury
    Date Received
    October 19, 2018
    Report Date
    October 23, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PC-(B)(4). DATE SENT TO THE FDA: (B)(4) 2018. CORRECTED INFORMATION: ¿ IT WAS REPORTED THAT THIS DEVICE IS NOT MALFUNCTION REPORTABLE. THEREFORE, THIS MEDWATCH REPORT 2210968-2018-76653 IS NOT REPORTABLE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: 1.WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? -NO. 2.DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? - NO. 3.DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT INVOLVED? - NO.

    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. IF FURTHER DETAILS ARE RECEIVED AT THE 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 PRODUCT 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 PRODUCT INVOLVED? CITATION: J NEUROSURG SPINE. 2016; 24: 700¿707. DOI: HTTP://THEJNS.ORG/DOI/ABS/10.3171/2015.9.SPINE153 - [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: MICROSURGICAL TREATMENT OF SACRAL PERINEURAL (TARLOV) CYSTS: CASE SERIES AND REVIEW OF THE LITERATURE" AUTHOR: JOHN F. BURKE, MD , PHD, JAYESH P. THAWANI, MD , IAN BERGER, BS, NIKHIL R. NAYAK, MD ,JAMES H. STEPHEN, MD , TUNDE FARKAS, MD , HOVIK JOHN ASCHYAN, BA , JOHN PIERCE, MS, SUHAIL KANCHWALA, MD , DONLIN M. LONG, MD , PHD, AND WILLIAM C. WELCH, MD CITATION: J NEUROSURG SPINE. 2016; 24: 700¿707. DOI: HTTP://THEJNS.ORG/DOI/ABS/10.3171/2015.9.SPINE153. TARLOV CYSTS (TCS) OCCUR MOST COMMONLY ON EXTRADURAL COMPONENTS OF THE SACRAL AND COCCYGEAL NERVE ROOTS. THE AUTHORS INVESTIGATED THE EFFECTS OF SURGICAL INTERVENTION ON SYMPTOMATIC TCS AND AIM TO SOLIDIFY THE SURGICAL CRITERIA FOR THIS DISEASE PROCESS. THE AUTHORS PERFORMED A RETROSPECTIVE REVIEW OF DATA FROM 23 CONSECUTIVE PATIENTS (4 MALE AND 19 FEMALE PATIENTS; AGE: 26 TO 64 YEARS OLD) WHO WERE SURGICALLY TREATED FOR SYMPTOMATIC TCS FROM SEPTEMBER 2011 TO MARCH 2013. DURING THE SURGICAL PROCEDURE, INCISION AND EXPOSURE ARE CONDUCTED USING ANATOMICAL LANDMARKS. FOLLOWING INCISION INTO THE CYST WALL, A NUROLON 4-0 SUTURE (ETHICON) IS PLACED LATERAL TO THE OPENING ON EITHER SIDE TO BRING THE DURAL EDGES INWARD AND UNDER THE CLOSURE. REPORTED COMPLICATIONS INCLUDED INFECTION (N-1) WHICH REQUIRED RE-OPERATION, COPIOUS IRRIGATION, AND LONG-TERM INTRAVENOUS ANTIBIOTICS, AND THE PATIENT RECOVERED EXTREMELY WELL, PERSISTENT SYMPTOMS OF CSF HYPOTENSION (N-1) WHICH REQUIRED RE-OPERATION, CSF LEAKAGE (N-1) WHICH REQUIRED EXPLORATION AND CLOSURE OF THE CSF LEAK AND SLOWLY IMPROVED AFTERWARDS, PERSISTENT CSF LEAKAGE (N-1) WHICH REQUIRED RE-OPERATION, PERSISTENT CSF LEAK (N-1) WHICH PURSUED REFERRAL FOR A SECOND OPINION AND SHUNT PLACEMENT AFTER 3 RE-OPERATIONS, AND LARGE PSEUDOMENINGOCELE (N-1) WHICH REQUIRED RE-OPERATION. IT WAS REPORTED THAT THIS IS ONE OF THE LARGEST PUBLISHED STUDIES ON PATIENTS WITH TCS TREATED MICROSURGICALLY. THE DATA SUGGEST THAT PATIENTS WITH SYMPTOMATIC TCS MAY BENEFIT FROM OPEN MICROSURGICAL TREATMENT. ALTHOUGH OUTCOMES SEEM RELATED TO PATIENT AGE, DURATION OF SYMPTOMS, AND EXTENT OF DISEASE DEMONSTRATED ON IMAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824070 NUROLON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NON ABSORBABLE, SYNTHETIC, POLYAMIDE GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention