BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE

    MDR report key: 25153855 · Received May 12, 2026

    Report

    Report Number
    2210968-2026-05196
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    June 1, 2025
    Report Date
    May 12, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 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. 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: BFUDJ, VOLUME 15; ISSUE 1 (JUNE) 2025 HTTPS://DOI.ORG/10.5958/2230-7273.2025.00004.7.

    Description of Event or Problem · 0

    TITLE: MODIFIED TRANSCONJUNCTIVAL INCISION FOR ZYGOMATIC AND ORBITAL FLOOR FRACTURE ¿ A CLINICAL REPORT. THE AIM OF THIS STUDY IS TO EVALUATE THE CLINICAL, FUNCTIONAL, AND AESTHETIC OUTCOMES OF THE Y-MODIFIED TRANSCONJUNCTIVAL APPROACH IN THE TREATMENT OF ZMC FRACTURES WITH ORBITAL FLOOR INVOLVEMENT. BETWEEN JUNE 2023 AND DECEMBER 2024, CONDUCTED AT THE DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, JSS DENTAL COLLEGE, MYSORE. A TOTAL OF 11 PATIENTS WITH ZYGOMATICOMAXILLARY COMPLEX (ZMC) FRACTURES WERE INCLUDED, WITH A MALE PREDOMINANCE (81.82%) AND A MEAN AGE OF 34.27 PLUS OR MINUS 9.58 YEARS. THE LOWER EYELID WAS EVERTED AND STABILIZED USING THREE TRACTION SUTURES (3-0 MERSILK, ETHICON INC., SOMERVILLE, NJ, USA) PLACED THROUGH THE TARSUS MEDIALLY, CENTRALLY, AND LATERALLY. CLOSURE WAS PERFORMED IN THE FOLLOWING LAYERS: LATERAL CANTHAL LIGAMENT AND ORBICULARIS OCULI WITH 4-0 POLYGLACTIN 910 (VICRYL, ETHICON INC., SOMERVILLE, NJ, USA), CONJUNCTIVA WITH 5-0 POLYGLACTIN 910 (VICRYL), INTRAORAL MUCOSA WITH 4-0 POLYGLACTIN 910 (VICRYL), AND SKIN WITH 5-0 POLYPROPYLENE (PROLENE, ETHICON INC., SOMERVILLE, NJ, USA) IN A Y CONFIGURATION. REPORTED COMPLICATIONS ARE : THREE TRACTION SUTURES (3-0 MERSILK, ETHICON) -ENOPHTHALMOS NOTED (N=1) TREATMENT: NOT PROVIDED 4-0, 5-0 POLYGLACTIN 910 (VICRYL, ETHICON) -ENOPHTHALMOS NOTED (N=1) TREATMENT: NOT PROVIDED 5-0 POLYPROPYLENE (PROLENE, ETHICON) -ENOPHTHALMOS NOTED (N=1) TREATMENT: NOT PROVIDED. IN CONCLUSION, THE Y-MODIFIED TRANSCONJUNCTIVAL APPROACH PROVIDES EXCELLENT EXPOSURE WITH MINIMAL MORBIDITY, EFFECTIVE FRACTURE STABILIZATION, AND FAVORABLE FUNCTIONAL AND AESTHETIC OUTCOMES IN PATIENTS WITH ZMC FRACTURES WITH ORBITAL FLOOR INVOLVEMENT. LARGER STUDIES ARE REQUIRED TO CONFIRM THE BROADER CLINICAL APPLICABILITY OF THIS METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441178 SILK SUTURE SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other