BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 8233266 · Received January 10, 2019

    Report

    Report Number
    2210968-2019-78306
    Event Type
    Injury
    Date Received
    January 10, 2019
    Report Date
    December 27, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (SILK SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (SILK SUTURE) USED IN THIS PROCEDURE? CITATION: ORAL MAXILLOFAC SURG. 2014; 18: 459¿464. DOI: 10.1007/S10006-013-0439-9. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "ACCIDENTS AND COMPLICATIONS ASSOCIATED TO THIRD MOLAR SURGERIES PERFORMED BY DENTISTRY STUDENTS." AUTHORS: MARCELO RODRIGUES AZENHA, ROGERIO BENTES KATO, RENAN BARROS LIMA BUENO, PATRICIO JOSE OLIVEIRA NETO, MICHEL CAMPOS RIBEIRO. CITATION: ORAL MAXILLOFAC SURG. 2014; 18: 459¿464. DOI: 10.1007/S10006-013-0439-9. THE AIM OF THIS WORK IS TO DEMONSTRATE THE ACCIDENTS AND COMPLICATIONS RATES ON THIRD MOLARS SURGERIES PERFORMED BY SENIOR DENTISTRY STUDENTS. A RETROSPECTIVE STUDY OF 88 PATIENT (26 MALE AND 62 FEMALE PATIENTS; AGE: 24 YEARS) CHARTS SUBMITTED TO THIRD MOLARS SURGERIES WAS DONE. DURING THE SURGICAL PROCEDURE, ALL PATIENTS WENT THROUGH SIMILAR SURGICAL TECHNIQUES, USING ELEVATORS AND/OR FORCEPS BESIDES OSTEOTOMY AND ODONTOSECTION, WHEN NECESSARY, BY USING DRILLS IN HIGH SPEED ELECTRIC ENGINE UNDER ABUNDANT IRRIGATION. IMMEDIATELY AFTER THE TOOTH EXTRACTIONS, THE CARES CONCERNING THE SOCKET WERE PERFORMED, AND THE SUTURES WERE DONE WITH SILK SUTURE THREAD 4-0 (ETHICON). REPORTED COMPLICATIONS INCLUDED DRY SOCKET (N-3) WHICH REQUIRED ALVEOLUS IRRIGATION WITH STERILIZED SALINE SOLUTION AND WITH THE USE OF ALVEOSAN, FOLLOWED BY SIMPLE SUTURES, SUTURE DEHISCENCE (N-3) WHICH REQUIRED GOOD ORAL HYGIENE AND LOCAL CLEANING WITH PERIOGARD, AND INFECTION (N-1) WHICH REQUIRED AMOXICILLIN PRESCRIPTION AND LOCAL CLEANING WITH PERIOGARD. IT WAS CONCLUDED THAT THE SURGEON¿S LACK OF EXPERIENCE IS NOT CRUCIAL FOR THE INCREASE OF THE ACCIDENT AND COMPLICATION RATE IN THIRD MOLAR SURGERIES; FEMALE PATIENTS SHOW HIGHER ACCIDENT AND COMPLICATION RATES, POSSIBLY DUE TO THE HIGHER NUMBER OF SURGERIES IN THIS GROUP OF PATIENTS; AND THE ACCIDENT AND COMPLICATION RATES FOUND IN THIS STUDY ARE SIMILAR TO PREVIOUS STUDIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28587 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention