BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUROLON NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 16902874 · Received May 10, 2023

    Report

    Report Number
    2210968-2023-03505
    Event Type
    Injury
    Date Received
    May 10, 2023
    Report Date
    May 10, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2023-03505 AND 2210968-2023-03506. CITATION: WORLD NEUROSURG. (2023) 170:E629-E638. HTTPS://DOI.ORG/10.1016/J.WNEU.2022.11.079.

    Description of Event or Problem · 0

    TITLE: POSTNATAL SURGICAL CORRECTION OF MYELOMENINGOCELES: PREOPERATIVE AND INTRAOPERATIVE RISK FACTORS ASSOCIATED WITH POSTOPERATIVE NEUROLOGIC OUTCOMES. WE PRESENT A RETROSPECTIVE ANALYSIS OF A PROSPECTIVE COHORT OF PATIENTS WHO WERE TREATED WITH POSTNATAL SURGICAL CORRECTION FOR MYELOMENINGOCELE (MMC), EVALUATING THE POSSIBLE PREOPERATIVE AND INTRAOPERATIVE RISK FACTORS ASSOCIATED WITH THEIR FUNCTIONAL NEUROLOGIC OUTCOMES. BETWEEN 2007 AND 2018, 52 SURGICAL PROCEDURES WERE PERFORMED FOR MMCS. THERE WERE 30 FEMALES (60%). THE MEDIAN AGE OF GESTATION AT SURGERY WAS 37.4 WEEKS. AFTER THE PLACODE WAS CIRCUMFERENTIALLY DISSECTED AND SEPARATED, THE IMBRICATION RECONSTRUCTION WAS PERFORMED USING A 5-0 OR 4-0 VYCRIL (JOHNSON & JOHNSON, NEW BRUNSWICK, NEW JERSEY, USA) OR NUROLON (NYLON SUTURE) (ETHICON, SOMERVILLE, NEW JERSEY, USA). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: (N=2) CHIARI MALFORMATION TYPE 2, (N=13) ABNORMAL PSYCHOMOTOR DEVELOPMENT, (N=3) SPHINCTER NEUROGENIC DYSFUNCTION, (N=1) LIMITATION TO WALK, (N=4) CSF LEAKS, (N=1) INFECTION. DESPITE THERE BEING NO STATISTICALLY SIGNIFICANT ASSOCIATIONS WITH A TIMELY CLOSURE, ALL CASES WERE TREATED WITHIN THE FIRST 48 HOURS AND THIS COULD INFLUENCE THE LOW COMPLICATION RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231755 NUROLON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention