BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 23521526 · Received November 11, 2025

    Report

    Report Number
    3008766073-2025-00155
    Event Type
    Injury
    Date Received
    November 11, 2025
    Date of Event
    January 1, 2025
    Report Date
    November 11, 2025
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 11/11/2025 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. 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: TITLE: BREAKING THE 15-MM BARRIER: LIBERAL RING SIZING AND INDEX 30-MM BALLOON DILATION MINIMIZE POST-MAGNETIC SPHINCTER AUGMENTATION DYSPHAGIA IN A 10- YEAR RETROSPECTIVE COHORT. AUTHORS: IFRAH FATIMA, SREENI JONNALAGADDA CITATION: NOT PROVIDED. THIS STUDY AIMS TO ANALYZE RETROSPECTIVE DATA OVER 10 YEARS TO IDENTIFY PREDICTORS OF POST-MSA DYSPHAGIA AND COMPARED INITIAL 30 MM DILATION (OVER THE WIRE UNDER FLUOROSCOPIC GUIDANCE) STRATEGY VS CONVENTIONAL (< 20 MM DILATION) THROUGH THE SCOPE (TTS). BETWEEN JANUARY 2014 TO JANUARY 2025, A TOTAL OF N=304 PATIENT UNDERWENT MAGNETIC SPHINCTER AUGMENTATION (MSA) USING THE LINX® DEVICE FOR REFRACTORY GERD. REPORTED COMPLICATIONS ARE LINX® DEVICE. N=74 DYSPHAGIA TREATMENT: ENDOSCOPIC DILATION. IN CONCLUSION, THIS 10-YEAR RETROSPECTIVE COHORT, LARGER MSA SIZE WAS SIGNIFICANTLY ASSOCIATED WITH LOWER POST-MSA DYSPHAGIA, AND TREATING DYSPHAGIA WITH A SINGLE 30 MM DILATION (AS OPPOSED TO STEP UP DILATION PER MANUFACTURER¿S RECOMMENDATIONS) REDUCED THE REPEAT-PROCEDURE RATE BY 76% WITHOUT ADDED MORBIDITY (NNT = 4). OUR DATA HIGHLIGHTS TWO MODIFIABLE FACTORS THAT CAN IMPROVE LONG-TERM DYSPHAGIA OUTCOMES. PROSPECTIVE MULTICENTER DATA FROM PHYSIOLOGIC MANOMETRIC STUDIES (SUCH AS ESOFLIP) ARE NEEDED TO VALIDATE THESE FINDINGS AND REFINE PROTOCOLS FOR ENDOSCOPIC THERAPY IN POST-MSA DYSPHAGIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1927049 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention