BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUROLON NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 16903945 · Received May 10, 2023

    Report

    Report Number
    2210968-2023-03510
    Event Type
    Injury
    Date Received
    May 10, 2023
    Date of Event
    February 22, 2021
    Report Date
    May 10, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # :(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 ASYMPTOMATIC PNEUMOCEPHALUS 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. RELATED EVENTS CAPTURED VIA 2210968-2023-03509 AND 2210968-2023-03510. CITATION: J NEUROL SURG B SKULL BASE 2022;83:359¿366; DOI.

    Description of Event or Problem · 0

    TITLE: RECONSTRUCTIVE OUTCOMES OF MULTILAYERED CLOSURE OF LARGE SKULL BASE DURAL DEFECTS FOLLOWING OPEN ANTERIOR CRANIOFACIAL RESECTION THE STUDY REPORTS THE OUTCOMES AND TECHNIQUE OF A MULTILAYERED RECONSTRUCTIVE ALGORITHM UTILIZING LOCAL TISSUE, DURAL GRAFT MATRIX, AND MICROVASCULAR FREE TISSUE TRANSFER (MVFTT) FOR RECONSTRUCTION OF LARGE OPEN ANTERIOR SKULL BASE DEFECTS WITH DURAL RESECTION DEFORMITIES. BETWEEN (B)(6) 2015 AND (B)(6) 2020, 11 PATIENTS WITH LARGE OPEN ANTERIOR SKULL BASE DEFECTS WITH DURAL RESECTION DEFORMITIES WERE INCLUDED IN THE STUDY. THERE WERE 10 MALES AND 1 FEMALE WITH A MEAN AGE OF 48 YEARS .THE MOST COMMON PATHOLOGIC INDICATION FOR OPEN ANTERIOR CRANIOFACIAL RESECTION WAS SQUAMOUS CELL CARCINOMA (7 PATIENTS), WITH THE AVERAGE DURAL DEFECT RENDERED BEING 36.0 +/-25.9 CM2. 5 PATIENTS REQUIRED CONCURRENT ORBITAL EXENTERATION AND EIGHT REQUIRED CONCURRENT MAXILLECTOMY. DURING THE REPAIR OF OPEN ANTERIOR SKULL BASE DEFECTS PROCEDURE, DURAL DEFECTS ARE PREFERENTIALLY REPAIRED BY USING A COMPETITOR DURAL GRAFT MATRIX (MANUFACTURER: INTEGRA). THE DURAL GRAFT MATRIX IS SUTURED BY USING 3¿0 NUROLON (ETHICON) IN A RUNNING FASHION TO ENSURE AS CLOSE TO A WATERTIGHT CLOSURE AS POSSIBLE. THIS IS FOLLOWED BY A PERICRANIAL FLAP OVERLAY, WHICH IS SIMILARLY SUTURED IN PLACE. ALL PATIENTS UNDERWENT A MULTILAYERED RECONSTRUCTION WITH 9 UNDERGOING COMBINED DURAL GRAFT MATRIX, PERICRANIAL FLAP, AND MICROVASCULAR FREE TISSUE TRANSFER, AND 2 UNDERGOING DURAL GRAFT MATRIX AND MICROVASCULAR FREE TISSUE TRANSFER WITH OVERLAY VASCULARIZED FASCIA DUE TO LOSS OF PERICRANIAL TISSUE. THE REPORTED COMPLICATIONS INCLUDED PATIENT 5, A 39-YEAR-OLD MALE WITH ASYMPTOMATIC PNEUMOCEPHALUS DETECTED ON ROUTINE POSTOPERATIVE CT SCANS (N=1) AND PATIENT 6, A 53-YEAR-OLD MALE WITH ASYMPTOMATIC PNEUMOCEPHALUS DETECTED ON ROUTINE POSTOPERATIVE CT SCANS (N=1). IN CONCLUSION, A STANDARDIZED MULTILAYERED CLOSURE TECHNIQUE OF DURAL GRAFT MATRIX, PERICRANIAL FLAP, AND MVFTT OVERLAY IN THE RECONSTRUCTION OF LARGE OPEN ANTERIOR CRANIOFACIAL DURAL DEFECTS CAN ASSIST THE RECONSTRUCTIVE TEAM IN APPROACHING THESE COMPLEX DEFORMITIES AND MAY HELP PREVENT POSTOPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687785 NUROLON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Other