BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 9536566 · Received December 31, 2019

    Report

    Report Number
    2210968-2019-91427
    Event Type
    Injury
    Date Received
    December 31, 2019
    Report Date
    December 10, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. CITATION: NOT REPORTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE : ARTHROSCOPIC TREATMENT OF THE ACUTE AND CHRONIC ANTERIOR INSTABILITY OF THE SHOULDER-EARLY RESULTS". AUTHOR : E.ANTONOGIANNAKIS, C.KARLIAFTIS, C.K.YIANNAKOPOULOS, P.LABRINAKOS. CITATION: NOT REPORTED. THE PURPOSE OF THIS STUDY WAS TO REPORT THE RESULTS OF ARTHROSCOPIC SHOULDER STABILIZATION IN PATIENTS WITH TRAUMATIC ANTERIOR SHOULDER INSTABILITY. BETWEEN SEPTEMBER 1999 AND AUGUST 2000, 42 MALE PATIENTS WITH ACUTE AND CHRONIC SHOULDER INSTABILITY UNDERWENT SURGICAL STABILIZATION. NON ABSORBABLE ETHIBOND # 2 SUTURES (ETHICON) HAVE USUALLY BEEN USED. USING SPECIALLY DESIGNED INSTRUMENTS, A SUTURE IS PASSED THROUGH THE CAPSULE, STARTING AT THE ANTERIOR INFERIOR GLENOHUMERAL LIGAMENT. REPORTED COMPLICATION INCLUDED IMPINGEMENT SYNDROME WITH SHOULDER PAIN (N-?) WHICH WAS TREATED CONSERVATIVELY WITH SUCCESS, BY PHYSIOTHERAPY PROGRAM CHANGE, SUTURE BREAKAGE (N-?), AND STIFFNESS LASTING MORE THAN 4 MONTHS (N-?) WHICH WAS TREATED WITH INTENSIFICATION OF THE PHYSIOTHERAPY PROGRAM. IN CONCLUSION, THE ARTHROSCOPIC RECONSTRUCTION OF ANTERIOR TRAUMATIC INSTABILITY IS A VERY PROMISING TECHNIQUE PROVIDING EXCELLENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329984 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention