MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX 1.5 16 BEAD US; ANTI-REFLUX IMPLANT

Catalog Number	LXMC16
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 1/14/2026.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.
Event or Problem Description
It was reported via journal article : this complaint is from a literature source.The following literature cite has been reviewed: yogeswaran muthukumaru , ajibola adebisi , mubarik rehman , dhiren nehra bjs, volume 112, issue supplement_17, december 2025 (pubmed citation not available) a 37-year-old male with a 5-year history of gastro-oesophageal reflux disease (gord) symptoms¿heartburn and regurgitation¿was referred for surgical intervention.He was intolerant of proton pump inhibitors and managed with cimetidine.Laparoscopy revealed a small (3 cm) sliding hiatus hernia.Key steps included crural dissection, mobilisation of the oesophagus, and primary hiatus hernia repair using interrupted ethibond sutures.The vagus nerve were identified and preserved.A tunnel was created posterior to the oesophagus at the goj, the oesophageal circumference was measured using a sizing tool, and a size 16 linx device was implanted.Reported complications include persistent dysphagia at 1-year follow-up.In conclusion, this case highlights the utility of linx in selected gord patients and discusses management of persistent postoperative dysphagia.

• Brand Name: LINX 1.5 16 BEAD US
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4545 creek road; cincinnati OH
• Manufacturer Contact: orla o'mahony ; 4545 creek rd.; cincinnati, OH 45242 ; 3035526892
• MDR Report Key: 24066491
• Report Number: 3008766073-2026-00008
• Device Sequence Number: 9350953
• Product Code: LEI
• UDI-Device Identifier: 00855106005363
• UDI-Public: 00855106005363
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: LXMC16
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male