BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 18937403 · Received March 19, 2024

    Report

    Report Number
    2210968-2024-03234
    Event Type
    Injury
    Date Received
    March 19, 2024
    Date of Event
    March 30, 2022
    Report Date
    March 19, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED RELATED EVENTS CAPTURED VIA 2210968-2024-03233 AND 2210968-2024-03234 CITATION: INTERDISCIPLINARY NEUROSURGERY: ADVANCED TECHNIQUES AND CASE MANAGEMENT 29 (2022) 101549; HTTPS://DOI.ORG/10.1016/J.INAT.2022.101549.

    Description of Event or Problem · 0

    TITLE: REVIEW OF TRANSORAL ODONTOIDECTOMY. WHERE DO WE STAND? TECHNICAL NOTE AND A SINGLE-CENTER EXPERIENCE THIS STUDY REVIEWS THE SURGICAL APPROACH AND OUR 10-YEAR SINGLE-CENTER EXPERIENCE OF TRANSORAL ODONTOIDECTOMY. FROM 2010 TO 2020, 10 PATIENTS WITH SYMPTOMATIC COMPRESSIVE PATHOLOGIES AT THE CRANIOCERVICAL JUNCTION WHO UNDERWENT TRANSORAL ODONTOIDECTOMIES WERE INCLUDED IN THE STUDY. THERE WERE 8 MALES AND 2 FEMALES WITH AMEAN AGE WAS 60 YEARS (RANGE 24 TO 78). ALL PATIENTS UNDERWENT TRANSORAL ODONTOIDECTOMY AND TREATMENT OF VENTRALLY COMPRESSIVE PATHOLOGY AT THE CRANIOCERVICAL JUNCTION. DURING THE PROCEDURE, AFTER CONFIRMATION OF SATISFACTORY BONY REMOVAL EITHER ON STEREOTAXY OR INTRAOPERATIVE FLUOROSCOPY, THE POSTERIOR PHARYNGEAL WALL IS CLOSED IN DOUBLE-LAYER FASHION USING 3¿0 VICRYL SUTURES (ETHICON) STARTING WITH THE MUSCULAR LAYER FOLLOWED BY THE MUCOSA. SMALL AMOUNT OF ANTIBIOTIC IRRIGATION IS USED ON THE INCISION. DUE TO RISK OF TONGUE EDEMA, PATIENTS WERE TYPICALLY KEPT INTUBATED POST-OPERATIVELY. THEY ARE MONITORED IN THE INTENSIVE CARE UNIT UNTIL THE PATIENT IS DEEMED SUITABLE FOR EXTUBATION BASED ON THE MAGNITUDE OF RETRACTION EDEMA AND ENDOTRACHEAL TUBE CUFF LEAK. REPORTED COMPLICATIONS INCLUDED PATIENT 2, A 76-YEAR-OLD PATIENT HAD RETROPHARYNGEAL ABSCESS ASSOCIATED WITH OSTEOMYELITIS (N=1), AND PATIENT 3, A 47-YEAR-OLD MALE PATIENT HAD PHARYNGEAL WOUND DEHISCENCE (N=1) IN CONCLUSION, THE INTRA AND POST-OPERATIVE COMPLICATIONS WE REPORT REPRESENT THE COMMON PITFALLS. HIGHLY SPECIALIZED AND COMPREHENSIVE PATIENT CARE REMAINS ESSENTIAL AS POST-OPERATIVE COMPLICATION RATES REMAIN HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1411947 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention