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

Catalog Number	LXMC14
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Heartburn/Indigestion (1883); Insufficient Information (4580)
Date of Event	08/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a linx implant occurred on (b)(6) 2018 explant (b)(6) 2025 lxmc (b)(6) 2018: patient reports improvement in symptoms since the implant however does report some intermittent coughing symptoms.They noted recurrence of symptoms about a 9 year interval after his placement.Pt had a couple of endoscopies and then surgeon asked patient to get some imaging and which confirmed a disrupted device.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/26/2026.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.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.No lot number was provided therefore a device history could not be done.Additional information received: spoke with patient who indicated his device was implanted in 2016.He confirmed the correct implant date is (b)(6) 2016.Patient also reported that since the second device has been implanted, his gerd has improved.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 exact date of implant? the event description states ¿noted recurrence of symptoms ¿.What symptoms lead to the discovery of the discontinuous device? when did they begin? what was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.Please send to: (b)(6).What is the device lot number? was the device initially effective in controlling reflux? were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? did the patient undergo an mri since device implant? if so, when was the mri and what strength? what was anatomical position of the mri? did the patient have any other surgeries in the area? did the patient receive any dilations while the linx was implanted? was any additional imaging performed since device implant? does the device appear to be in a continuous annular state in these images? we are interested in establishing a window when the device may have become discontinuous.Please share any additional images.What is the management plan? is device removal scheduled? is a replacement linx or fundoplication planned? when and if the explanation takes place can we ask that the procedure gets video recorded and the video shared? when and if the linx device is removed, may we ask that the device be returned for analysis? 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 3/30/2026.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/21/2026.Additional information was requested, and the following was obtained: what was the exact date of implant? the event description states ¿noted recurrence of symptoms ¿.What symptoms lead to the discovery of the discontinuous device? when did they begin? patient reports improvement in his symptoms since the implant however does report some intermittent coughing symptoms.Patient had concerns about linx recalls and therefore completed a phone follow up.In 2025, we noted recurrence of symptoms about a 9 year interval after his placement.He had a couple of endoscopies and then surgeon asked him to get some imaging and which confirmed a disrupted device.What was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.Please send to: productcompliant1@its.Jnj.Com.What is the device lot number? n/a.Was the device initially effective in controlling reflux? yes.Were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? coughing.Did the patient undergo an mri since device implant? if so, when was the mri and what strength? na.What was anatomical position of the mri? n/a.Did the patient have any other surgeries in the area? no.Did the patient receive any dilations while the linx was implanted? unsure.Was any additional imaging performed since device implant? does the device appear to be in a continuous annular state in these images? we are interested in establishing a window when the device may have become discontinuous.Please share any additional images.What is the management plan? is device removal scheduled? is a replacement linx or fundoplication planned? na.Device investigation: a 14 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.Bent wires and tooling marks were noted in some beads.A linx device with a visible weld ball that disconnected from a washer was returned to the analysis site.The link length and tensile force measurements were found to meet the applicable specifications during device analysis.The remaining device characteristics, excepting the visible weld ball, show no anomalies for a device that has been reasonably changed as part of the explant procedure.The device was scanned using computer tomography (ct), optical microscopy, and scanning electron microscopy.The washer through-hole at the separation was measured and was greater than the specification.The washer through-hole was concentric with small amount of material displacement at the outer edge of the through hole.The overall appearance of the surface of the washer through hole didn¿t exhibit gross loss of shape.The top view of the diameter of the exposed weld ball was measured.This diameter is within the specification.The weld ball was concentric with the respect to the wire.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.

• 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 ; 3035526892
• MDR Report Key: 24697822
• Report Number: 3008766073-2026-00043
• Device Sequence Number: 10166980
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• 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 Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2026

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: LXMC14
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 03/27/2026; 04/09/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 03/30/2026; 04/21/2026
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2038-2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male