BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 23631825 · Received November 24, 2025

    Report

    Report Number
    3008766073-2025-00162
    Event Type
    Injury
    Date Received
    November 24, 2025
    Date of Event
    October 30, 2025
    Report Date
    November 24, 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: 11/24/2025 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: SALEHI N, LUO S, MARSHALL T, ASADI HA, TURAGA A, ALQAMISH M, SAHA S, GREENBERG J, FINNERTY BM, FAHEY III TJ, ZARNEGAR R. OUTCOMES OF SAME-DAY DISCHARGE FOLLOWING ROBOTIC HIATAL HERNIA REPAIR: A COMPARATIVE STUDY. J GASTROINTEST SURG. 2025 OCT 30:102270.DOI:10.1016/J.GASSUR.2025.102270. EPUB AHEAD OF PRINT. PMID: 41176213. THIS STUDY AIMS TO IDENTIFY FACTORS AFFECTING PATIENT SELECTION FOR SDD AT A TERTIARY CENTER AND COMPARE THE OUTCOMES OF SDD WITH EXTENDED OBSERVATION STAY (EOS) AFTER ROBOTIC HIATAL HERNIA REPAIR. FROM JANUARY 2012 TO APRIL 2024, WE RETROSPECTIVELY REVIEWED PATIENTS WHO UNDERWENT ROBOTIC HIATAL HERNIA REPAIR. AMONG 740 INCLUDED PATIENTS, 464 WERE EXTENDED OBSERVATION STAY (EOS) AND 276 WERE SAME-DAY DISCHARGE (SDD). THEY ALSO UNDERWENT MORE REVISIONAL SURGERIES AND NISSEN FUNDOPLICATIONS (P=0.028), WHILE SDD PATIENTS MORE FREQUENTLY RECEIVED MAGNETIC SPHINCTER AUGMENTATION (P=0.007). THE MEAN DURATION FOLLOW-UP WAS NOT REPORTED. REPORTED COMPLICATIONS: LINX REFLUX MANAGEMENT SYSTEM (ETHICON ENDO SURGERY): (N=?) GERD SYMPTOMS TREATMENT: NOT REPORTED. (N=?) DYSPHAGIA TREATMENT: NOT REPORTED. (N=?) PARAESOPHAGEAL HERNIA TREATMENT: ER (EMERGENCY ROOM) RETURNS/READMISSION. IN CONCLUSION, SDD FOLLOWING ROBOTIC HIATAL HERNIA REPAIR IS SAFE AND FEASIBLE, WITH OUTCOMES SIMILAR TO EOS WHEN PATIENTS ARE APPROPRIATELY SELECTED. HIGHER ASA SCORE, DIABETES, PARAESOPHAGEAL HERNIA, AND TOUPET FUNDOPLICATION, COMPARED TO MAGNETIC SPHINCTER AUGMENTATION, ARE ASSOCIATED WITH INCREASED ER RETURNS AND READMISSIONS, HIGHLIGHTING THE NECESSITY FOR INDIVIDUALIZED PATIENT SELECTION. OPTIMIZING PERIOPERATIVE AND POSTOPERATIVE CARE CAN FURTHER IMPROVE SDD AFTER HIATAL HERNIA REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2748946 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention