BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 19255882 · Received May 6, 2024

    Report

    Report Number
    2210968-2024-05177
    Event Type
    Injury
    Date Received
    May 6, 2024
    Date of Event
    April 22, 2024
    Report Date
    May 30, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. AS NO CONTACT INFORMATION HAS BEEN PROVIDED, NO FOLLOW UP CAN OR WILL BE PERFORMED AT THIS TIME. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2024-05177 AND 2210968-2024-05178. CITATION: EUR SPINE J. 2024 APR 22.

    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. ADDITIONAL INFORMATION RECEIVED: THE FULL ARTICLE WAS RECEIVED: [3/0 MONOCRYL SUTURE (ETHICON)]: - WOUND DEHISCENCE OR SEROMA (N=8) TREATMENT: NOT SPECIFIED, BUT IT WAS STATED THAT (N=16) HAD RE-INTERVENTION DUE TO WOUND HEALING PROBLEMS - SUPERFICIAL INFECTION (N=12) TREATMENT: NOT SPECIFIED, BUT IT WAS STATED THAT (N=16) HAD RE-INTERVENTION DUE TO WOUND HEALING PROBLEMS - DEEP INFECTIONS (N=14) TREATMENT: NOT SPECIFIED, BUT IT WAS STATED THAT (N=16) HAD RE-INTERVENTION DUE TO WOUND HEALING PROBLEMS. ADDITIONAL INFORMATION: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. 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? CITATION: EUROPEAN SPINE JOURNAL (2024) 33:2261¿2268 HTTPS://DOI.ORG/10.1007/S00586-024-08224-7.

    Description of Event or Problem · 0

    TITLE: BARBED VERSUS CONVENTIONAL SUTURE IN ELECTIVE POSTERIOR SPINE SURGERY. THE AIM OF THIS STUDY WAS TO ANALYZE THE UTILITY OF BARBED SUTURES IN POSTERIOR SPINAL SURGERY IN ORDER TO PROVE NON-INFERIORITY TO CONVENTIONAL METHODS FOR WOUND CLOSURE. A TOTAL OF 483 PATIENTS WHO UNDERWENT ELECTIVE POSTERIOR SPINAL SURGERY IN WHICH BARBED (PROSPECTIVE) VERSUS CONVENTIONAL SUTURES (RETROSPECTIVE) WERE USED WAS ANALYZED. AMONG THESE, 183 PATIENTS IN THE BARBED GROUP AND 300 PATIENTS IN THE CONVENTIONAL GROUP. IN THE CONVENTIONAL GROUP, THE AUTHORS USED A TRADITIONAL LAYER-BY-LAYER CLOSURE TECHNIQUE WITH 2/0 ABSORBABLE MONOFILAMENT (LIKE NOVOSYN¿) OR 1/0 MONOFILAMENT (LIKE MONOMAX¿) FOR THE MUSCLE AND FASCIA LAYERS AND 3/0 MONOCRYL FOR THE SUBCUTANEOUS LAYER. IN THE BARBED GROUP THEY USED 1/0 OR 0/0 BARBED SUTURES (STRATAFIX¿, ETHICON, JOHNSON AND JOHNSON, US). REPORTED COMPLICATIONS IN THE CONVENTIONAL GROUP INCLUDE WOUND DEHISCENCE OR SEROMA (N=2.7%), SUPERFICIAL INFECTION (N=4.0%), DEEP INFECTION (N=4.7%), AND RE-INTERVENTION DUE TO WOUND HEALING PROBLEMS (N=5.3%). WHILE IN THE BARBED GROUP INCLUDE WOUND DEHISCENCE OR SEROMA (N=3.8%), SUPERFICIAL INFECTION (N=1.6%), DEEP INFECTIONS (N=2.7%), AND RE-INTERVENTION DUE TO WOUND HEALING PROBLEMS (N=4.9%). IN CONCLUSION, IN ELECTIVE POSTERIOR SPINAL PROCEDURES, THE USE OF BARBED SUTURES SIGNIFICANTLY REDUCED THE DURATION OF WOUND CLOSURE. THE WOUND HEALING PROCESS WAS NOT HINDERED AND THE ADDED COST RELATED TO THE SUTURE MATERIAL WAS SMALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768364 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention