BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VICRYL RAPIDE SUTURE

    MDR report key: 16572048 · Received March 20, 2023

    Report

    Report Number
    2210968-2023-01786
    Event Type
    Injury
    Date Received
    March 20, 2023
    Date of Event
    January 1, 2018
    Report Date
    March 20, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. 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. COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: CHINESE JOURNAL OF TISSUE ENGINEERING RESEARCH, 2018, 22 (35): 5607-5613. HTTPS://DOI.ORG/10.3969/J.ISSN.2095-4344.1006.

    Description of Event or Problem · 0

    TITLE: EFFICACY OF ADJUSTABLE EXTERNAL SUPPORT VERSUS HINGED EXTERNAL FIXATOR IN THE TREATMENT OF TERRIBLE TRIAD OF ELBOW. THE AIM OF THIS RETROSPECTIVE COHORT STUDY WAS TO COMPARE THE EFFICACY OF HINGED EXTERNAL FIXATOR AND EXTERNAL FIXATOR IN THE TREATMENT OF TERRIBLE TRIAD OF ELBOW JOINT. BETWEEN JANUARY 2013 TO JANUARY 2017, A TOTAL OF 65 PATIENTS (29 MALES AND 36 FEMALES; AVERAGE AGE OF 35.1 ± 8.1 YEARS) WITH THE "TERRIBLE TRIAD OF THE ELBOW" ADMITTED IN THE ZHUJIANG HOSPITAL OF SOUTHERN MEDICAL UNIVERSITY WERE INCLUDED IN THE STUDY. THE COLLATERAL OPERATION WAS PERFORMED COMBINED WITH LATERAL AND MEDIAL SURGERY APPROACHES OF THE ELBOW JOINT FOR THE OPEN REDUCTION AND FIXATION OF THE CAPITULUM RADIAL AND CORONOID FRACTURE, AND REPAIR OF THE LIGAMENT. A VICRYL RAPIDE ABSORBABLE SUTURE, JOHNSON & JOHNSON MEDICAL EQUIPMENT CO., LTD., BATCH NUMBER: 3650766 WAS USED DURING SURGERY. ACCORDING TO EXTERNAL FIXATION AFTER SURGERY, PATIENTS WERE DIVIDED INTO TWO GROUPS. SUPPORT GROUP: 30 PATIENTS WERE TREATED WITH ADJUSTABLE EXTERNAL SUPPORT AFTER SURGERY. FIXATOR GROUP: 35 PATIENTS RECEIVED HINGED EXTERNAL FIXATOR AFTER SURGERY. REPORTED COMPLICATIONS INCLUDE HETEROTOPIC OSSIFICATION OF THE ELBOW (N=3) AND ARTICULAR VALGUS DEFORMITY HEALING (N=1). IN CONCLUSION, ADJUSTABLE EXTERNAL SUPPORT AND HINGED EXTERNAL FIXATOR HAVE THE SAME EFFECT ON ELBOW JOINT FLEXION AND EXTENSION ACTIVITY, RANGE OF FOREARM ROTATION, HEALING TIME AND MAYO SCORE, AND ADJUSTABLE EXTERNAL SUPPORT CAN REPLACE HINGED EXTERNAL FIXATOR UNDER CERTAIN CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8480 UNKNOWN VICRYL RAPIDE SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other