BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 21314519 · Received February 5, 2025

    Report

    Report Number
    2210968-2025-01400
    Event Type
    Injury
    Date Received
    February 5, 2025
    Date of Event
    January 1, 2023
    Report Date
    February 11, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). CORRECTED INFORMATION: B1, B2, H1 - ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE EVENT IS NOT RELATED TO THE DEVICE. THEREFORE, THIS MEDWATCH REPORT IS BEING VOIDED.

    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: WORLD NEUROSURG. (2023).HTTPS://DOI.ORG/10.1016/J.WNEU.2023.11.109.

    Description of Event or Problem · 0

    TITLE : MANAGEMENT OF PERSISTENT SYRINGOMYELIA IN PATIENTS OPERATED FOR CHIARI MALFORMATION TYPE 1. THE AIM OF THIS STUDY WAS TO ANTICIPATE THE ADVANCEMENT OF PERSISTENT SYRINGOMYELIA IN ASSOCIATION WITH CM1 AFTER PFD AND TO EVALUATE THE OPTIMAL SURGICAL STRATEGIES ON THE BASIS OF OUR RADIOLOGIC FINDINGS AND OUTCOMES. FORTY-NINE PATIENTS DIAGNOSED WITH CM1 ASSOCIATED WITH SYRINGOMYELIA WHO UNDERWENT SURGERY BETWEEN 2008 AND 2019 WERE INCLUDED IN THIS RETROSPECTIVE STUDY. A MINIMAL MYELOTOMY WAS CREATED AT THE CLOSEST POINT TO THE DORSAL SURFACE OF THE RELEVANT SPINAL CORD, AND A TUBE WAS INSERTED IN THE SYRINGO SUBARACHNOID SPACE TO EVACUATE THE SYRINX. THE TUBE WAS SECURED WITH 8.0 PROLENE SUTURE (FIGURE 1B). THE REPORTED COMPLICATION INCLUDED SURGICAL COMPLICATION (N=1) AND CSF LEAK (N=1). IN CONCLUSION, ON THE BASIS OF OUR EXPERIENCE, SYRINX DIAMETERS >10 MM AT THEIR THICKEST POINT, LENGTHS SPANNING MORE THAN 10 VERTEBRAE, AND ORIGINS IN THE UPPER CERVICAL REGION EXTENDING TO THE UPPER THORACIC REGION MAY NOT REGRESS AFTER INITIAL SURGERY AND MAY CONTINUE TO PRODUCE SYRINX-SPECIFIC SYMPTOMS, POTENTIALLY REQUIRING A SECOND SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363212 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention