BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 19180045 · Received April 25, 2024

    Report

    Report Number
    2210968-2024-04871
    Event Type
    Injury
    Date Received
    April 25, 2024
    Date of Event
    November 4, 2021
    Report Date
    April 25, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    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. 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 2210968-2024-04871 AND 2210968-2024-04872 CITATION: EUROPEAN SPINE JOURNAL (2022). HTTPS://DOI.ORG/10.1007/S00586-021-07050-5

    Description of Event or Problem · 0

    TITLE: LOCAL VANCOMYCIN THERAPY TO REDUCE SURGICAL SITE INFECTION IN ADULT SPINE SURGERY: A RANDOMIZED PROSPECTIVE STUDY. THE AIM OF THIS STUDY. THIS PROSPECTIVE RANDOMIZED CONTROLLED TRIAL HYPOTHESIZES THAT INTRA WOUND VANCOMYCIN REDUCES POSTOPERATIVE INFECTION. THIS PROSPECTIVE STUDY WAS PERFORMED FROM FEBRUARY 2018 TO OCTOBER 2019. IN THIS STUDY, 375 PATIENTS, INCLUDING 187PATIENTS IN THE TREATMENT GROUP AND 188 PATIENTS IN THE CONTROL GROUP, WERE STUDIED. AMONG THE PATIENTS, 228 HAD SURGERY WITHOUT INSTRUMENTATION, AND 147 HAD SURGERY WITH INSTRUMENTATION. DURING THE PROCEDURE, IN THE CONTROL GROUP, FASCIA AND SUBCUTANEOUS TISSUE WERE CLOSED WITH ABSORBABLE SUTURE VICRYL (ETHICON INC) AND THE SKIN WAS CLOSED WITH ABSORBABLE MONOCRYL, OR NYLON. AND IN TREATMENT GROUP, IN SURGICAL CASES, UP TO 2 LEVELS OF SPINE SURGERY, 1 G, AND IN CASES MORE THAN 2 LEVELS, 2 G OF VANCOMYCIN WERE USED. REPORTED COMPLICATION: SURGICAL SITE INFECTION(N-13) CONCLUSION: INTRA-WOUND VANCOMYCIN DOES NOT REDUCE THE RISK OF POSTOPERATIVE INFECTION IN SPINE SURGERY, AND IN ADDITION, IT CAN INCREASE THE RISK OF GRAM-NEGATIVE INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160829 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention