BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 22792960 · Received August 13, 2025

    Report

    Report Number
    3008766073-2025-00110
    Event Type
    Injury
    Date Received
    August 13, 2025
    Date of Event
    August 5, 2024
    Report Date
    August 13, 2025
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 8/13/2025. D4: BATCH#: UNK. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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/BATCH NUMBER HAS NOT BEEN PROVIDED. 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 AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE: THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: AL ASADI H, NAJAH H, LI Y, MARSHALL T, SALEHI N, TURAGA A, FINNERTY BM, FAHEY TJ 3RD, ZARNEGAR R. DETERMINATION OF CAUSES OF POST-OPERATIVE DYSPHAGIA AFTER ANTI-REFLUX SURGERY BASED ON INTRA-OPERATIVE PLANIMETRY. SURG ENDOSC. 2024 OCT;38(10):5623-5633. DOI: 10.1007/S00464-024-11101-5. EPUB 2024 AUG 5. PMID: 39101988. THE AIM OF THIS STUDY IS TO INVESTIGATE THE VALUE OF PRE-OPERATIVE ESOPHAGEAL MOTILITY AS MEASURED BY HRM AND THE DEGREE OF CHANGE IN LES DISTENSIBILITY USING ENDOFLIP¿ TECHNOLOGY TO IDENTIFY PATIENTS AT RISK FOR DYSPHAGIA AFTER ANTI-REFLUX SURGERY (ARS). BETWEEN 2018 AND 2023, A TOTAL OF , 271 PATIENTS UNDERWENT INDEX ARS WITH PRE-OPERATIVE MANOMETRY AND INTRA-OPERATIVE ENDOFLIP¿. THE MAJORITY WERE FEMALE (56.4%), THE MEDIAN BMI WAS 26.8 IQR (23.9¿30.7) KG/MM2 AND THE MEDIAN AGE AT THE TIME OF SURGERY WAS 53 IQR (40¿63) YEARS. ONE-HUNDRED AND SEVENTEEN PATIENTS (43.1%) REPORTED PRE-OPERATIVE DYSPHAGIA, OF WHICH (28.2%) WAS MILD, (56.4%) WAS MODERATE, AND (15.3%) WAS SEVERE. SEVENTY-THREE PATIENTS (35.2%) WERE FOUND TO HAVE DYSMOTILITY ON PRE-OPERATIVE BARIUM SWALLOW . LINX PROCEDURE WAS PERFORMED IN STANDARD FASHION. REPORTED COMPLICATIONS ARE: LINX (ETHICON ENDOSURGERY), HIATAL HERNIA/REFLUX RECURRENCE (N=10), TREATMENT: RE-OPERATION, POST-OPERATIVE DYSPHAGIA AT 3 MONTHS FOLLOW-UP (N=2), TREATMENT: REOPERATION, NEW-ONSET OR WORSENING POST-OPERATIVE DYSPHAGIA AT 3-MONTH FOLLOW-UP (N=?), TREATMENT: NOT REPORTED. IN CONCLUSION, PATIENTS WHO DEVELOPED DYSPHAGIA POST-OPERATIVELY HAD POORER PRE-OPERATIVE MOTILITY AND A GREATER CHANGE IN LES CHARACTERISTICS INTRA-OPERATIVELY. THIS FINDING SUGGESTS THE UTILITY OF PRE-OPERATIVE MANOMETRY AND INTRA-OPERATIVE ENDOFLIP IN IDENTIFYING PATIENTS AT RISK OF DEVELOPING DYSPHAGIA POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75972 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention