MAUDE Adverse Event Report: Torax Medical, Inc. LINX; Anti-reflux implant

Catalog Number	LXMC15
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Heartburn/Indigestion (1883); Distress (2329)
Date of Event	07/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a linx removal procedure, the sales representative entered the operating room and observed the surgeon dissecting the linx device from the stomach.Following the procedure, the sales rep.Inquired whether the patient's condition would be revised to perform a gastric bypass; however, the surgeon indicated that the patient had already undergone a gastric bypass procedure.It was reported that the patient had experienced severe dysphagia associated with the linx implant, which also resulted in emotional distress.Additionally, the patient reportedly had a history of severe dysphagia prior to the initial linx implantation, which had been performed several years earlier.The device was removed during the procedure.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/11/2026.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.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.No lot or batch number was provided therefore a device history could not be done.Additional information was requested, and the following was obtained: prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? on what date did the implant take place? on what date did the explant take place? what is the lot number of the linx device? when using the linx sizing device what technique was used to determine the size? did the patient have an autoimmune disease? is the patient currently taking steroids / immunization drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? how severe was the dysphagia/odynophagia before intervention? were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? were there any other contributing factors that led to the removal of the device other than the reported dysphagia? besides the reported dysphagia, what was the reason for removal of the linx device? what was the reason for removal of the linx device? was the device found in the correct position/geometry at the time of removal? have the symptoms resolved since the device was explanted? i¿m just not going to have many of the details you seek.Date of implant unknown.(b)(6) 2026-explant performed.It was stated by the surgeon that the original notes stated that the measurement of the implant was determined as 3 sizes higher than the sizer pop-off.According to the surgeon, patient presented with unresolved dysphagia and gerd prior to the explant performed.

• Brand Name: LINX
• 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 ; +1(303)552-6892
• MDR Report Key: 50208913
• Report Number: 3008766073-2026-00094
• Device Sequence Number: 10009178
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: LXMC15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 08/11/2026
• 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 Sex: Unknown