BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 23393196 · Received October 27, 2025

    Report

    Report Number
    2210968-2025-12221
    Event Type
    Injury
    Date Received
    October 27, 2025
    Date of Event
    August 19, 2023
    Report Date
    October 27, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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: GLOBAL SPINE J. 2025 MAR;15(2):526-533. HTTPS://DOI.ORG/10.1177/21925682231196828. EPUB 2023 AUG 19. PMID: 37596811; PMCID: PMC11877658.

    Description of Event or Problem · 0

    TITLE: THE 5-FACTOR MODIFIED FRAILTY INDEX IS ASSOCIATED WITH INCREASED RISK OF REOPERATIONS AND ADJACENT LEVEL DISEASE FOLLOWING SINGLE-LEVEL TRANSFORAMINAL LUMBAR INTERBODY FUSION. THE AIM OF THIS STUDY IS TO DETERMINE THE PREDICTIVE CAPABILITY BETWEEN THE 5-FACTOR MODIFIED FRAILTY INDEX (MFI-5) SCORES AND ADVERSE CLINICAL AND RADIOGRAPHIC OUTCOMES FOLLOWING SINGLE-LEVEL TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). BETWEEN 2012 AND 2021, A TOTAL OF 156 PATIENTS WERE INCLUDED IN THE STUDY AND GROUPED ACCORDING TO THEIR LEVEL OF FRAILTY: NO-FRAILTY (MFI = 0, N = 67), MILD-FRAILTY (MFI = 1, N = 59), AND SEVERE-FRAILTY (MFI = 2+, N = 30) AGE OF 50 UNDERGOING SINGLE-LEVEL OPEN OR MINIMALLY INVASIVE TLIF. NO SIGNIFICANT DIFFERENCES WERE OBSERVED ACROSS FRAILTY GROUPS REGARDING GENDER DISTRIBUTION (P = .457), BMI (P = .949), OR SURGICAL TECHNIQUE USED (P = .819). DISCECTOMY WAS PERFORMED USING A SERIES OF SHAVERS AND CURETTES, AND TRIAL CAGES WERE THEN USED TO DETERMINE THE CORRECT SIZE. AFTER THE DISC SPACE WAS FILLED WITH LOCAL BONE GRAFT (FROM FACET/LAMINA) AND ALLOGRAFT. ONCE THIS WAS DONE, THE WOUND WAS THOROUGHLY IRRIGATED, AND THE FASCIA WAS CLOSED WITH ABSORBABLE VICRYL SUTURE. THE SKIN WAS CLOSED WITH ABSORBABLE MONOCRYL SUTURE, FINAL CONFIRMATORY IMAGING WAS TAKEN, AND THE PATIENT WAS EXTUBATED PROMPTLY. SIMILARLY, BILATERAL PEDICLE SCREWS AND RODS WERE PLACED USING STANDARD ANATOMIC LANDMARKS AND FLUOROSCOPY. ONCE THIS WAS DONE, THE WOUND WAS THOROUGHLY IRRIGATED, AND THE FASCIA WAS CLOSED WITH ABSORBABLE VICRYL SUTURE. THE SKIN WAS CLOSED WITH ABSORBABLE MONOCRYL SUTURE, FINAL CONFIRMATORY IMAGING WAS TAKEN, AND THE PATIENT WAS EXTUBATED PROMPTLY. THE MEAN DURATION FOLLOW-UP WAS 1 YEAR. REPORTED COMPLICATION: VICRYL SUTURE (ETHICON): MONOCRYL SUTURE (ETHICON): (N=6) DEEP AND SUPERFICIAL SURGICAL SITE INFECTIONS (SSIS). TREATMENT: NOT REPORTED. IN CONCLUSIONS, HIGH LEVELS OF FRAILTY WERE PREDICTIVE OF RELATED READMISSIONS, REOPERATIONS, ANY COMPLICATIONS, AND ASD IN OLDER ADULT PATIENTS UNDERGOING SINGLE-LEVEL TLIF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2308468 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other