BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATAFIX SPIRAL MONOCRYL PLUS UNKNOWN

    MDR report key: 21800216 · Received April 8, 2025

    Report

    Report Number
    2210968-2025-03717
    Event Type
    Injury
    Date Received
    April 8, 2025
    Date of Event
    February 1, 2025
    Report Date
    April 11, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: J CLIN NEUROSCI. 2025 APR;134:111108. HTTPS://DOI.ORG/10.1016/J.JOCN.2025.111108. EPUB 2025 FEB 8. PMID: 39923434.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). CORRECTED INFORMATION: B1, B2, H1 - ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE EVENT IS NOT RELATED TO THE DEVICE. THEREFORE, THIS MEDWATCH REPORT IS BEING VOIDED.

    Description of Event or Problem · 0

    TITLE: EXPANDED APPLICATIONS OF KNOTLESS TISSUE CONTROL DEVICES IN NEUROSURGICAL CRANIAL AND SPINAL APPLICATIONS. THIS STUDY AIMED TO EVALUATE THE APPLICATION OF KNOTLESS TISSUE CONTROL DEVICES IN VARIOUS CRANIAL AND SPINAL NEUROSURGICAL APPLICATIONS AS PART OF A QUALITY IMPROVEMENT INITIATIVE. A TOTAL OF 195 PATIENTS WHO UNDERWENT CRANIAL, SPINAL, AND PERIPHERAL NERVE NEUROSURGICAL PROCEDURES FROM 12/2022 UNTIL 7/2024 WERE INCLUDED IN THE STUDY. AMONG THESE, 53 (27.2 %) UNDERWENT CRANIAL, 140 (71.8 %) SPINE, AND 3 (1.0 %) PERIPHERAL NERVE PROCEDURES. A SWITCH IN SURGICAL REPAIR STRATEGY FROM CONVENTIONAL SUTURE TECHNIQUES TO STRATAFIX (ETHICON/J&J, RARITAN, NJ), KNOTLESS TISSUE CONTROL WAS PERFORMED IN 6/2023. A) CRANIAL APPLICATIONS FOR KNOTLESS SUTURE INCLUDE USE OF A 2¿0 PDS SPIRAL KNOTLESS FOR TEMPORALIS MUSCLE AND GALEAL CLOSURE FOLLOWED BY A 3¿0 MONOCRYL SPIRAL KNOTLESS FOR SUBCUTICULAR CLOSURE. B) SPINE TREATMENT INVOLVES CLOSURE OF MUSCULAR DEADSPACE WITH INTERRUPTED SUTURE FOLLOWED BY CLOSURE OF FASCIA WITH 0 PDS SYMMETRIC/BARBED KNOTLESS, DEEP AND SUBDERMAL TISSUE WITH 2¿0 PDS SPIRAL KNOTLESS, AND SUBCUTICULAR WITH 2¿0 MONOCRYL SPIRAL KNOTLESS. REPORTED COMPLICATIONS INCLUDE: 0 PDS SYMMETRIC STRATAFIX (ETHICON). 2¿0 PDS SPIRAL STRATAFIX (ETHICON). MONOCRYL SPIRAL STRATAFIX (2¿0 OR 3¿0; ETHICON). 44-YEAR-OLD FEMALE (N=1). CEREBROSPINAL FLUID LEAK AND MENINGITIS AFTER FAR LATERAL FOR FORAMEN MAGNUM MENINGIOMA RESECTION. TREATMENT: NOT REPORTED. IN CONCLUSION, KNOTLESS SUTURE TECHNIQUES CAN BE AN EFFECTIVE CLOSURE METHOD FOR A VARIETY OF NEUROSURGICAL TECHNIQUES COMPARABLE TO EXPECTED WOUND COMPLICATION RATES. WE EXPAND ON THE POTENTIAL APPLICATIONS OF THIS TECHNOLOGY COMPARED WITH PRIOR STUDIES. FURTHER STUDIES WILL BE NECESSARY TO CONFIRM THESE FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770081 STRATAFIX SPIRAL MONOCRYL PLUS UNKNOWN SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Other