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

Catalog Number	LXMC16
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heartburn/Indigestion (1883)
Date of Event	12/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a linx was explanted due to reoccurrence of uncontrolled heart burn and patient request for explant.Positive ph studies and converted to fundoplication.Patient is doing well.
Additional Manufacturer Narrative
(b)(4).Date sent 1/7/2026.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.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.No lot or batch number was provided therefore a device history could not be done.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: what was the implant date? what was the explant date? what is the lot number for the linx device? after implant, was the device initially effective in controlling reflux? when did the recurrent reflux begin? 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.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/16/2026.Investigation summary: a 16 beads linx device was returned in used condition.The device was returned in a locked position, in addition an attempt to unlocked was unsuccessfully made.A cut wire and bent wires were noted, and cosmetic damaged were noted.Overall review of the device function and dimensions show no anomalies from a device that has been reasonably changed as part of the explant procedure.Visual analysis was consistent with an explanted device, tooling marks were noted in some beads.Link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.Based on the results of this investigation, it was determined that the product met the manufacturing release criteria.The device lot number is unknown; therefore, the device history record could not be reviewed.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/5/2026.Additional information was requested, and the following was obtained: what was the implant date? what was the explant date? what is the lot number for the linx device? after implant, was the device initially effective in controlling reflux? when did the recurrent reflux begin? there has been no more information given to me.The patient is doing well.

• 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: 23988947
• Report Number: 3008766073-2026-00002
• Device Sequence Number: 14591034
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2026

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 01/15/2026; 02/05/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/16/2026; 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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