MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 13B; ANTI-REFLUX IMPLANT

Catalog Number	LXMC13
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/24/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a linx device was noted to be broken on recent cxr.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/9/2024 additional information was requested, and the following was obtained: what is the lot number? this is all i have in the records what symptoms lead to the discovery of the discontinuous device? when did they begin? cough, (b)(6) 2032.Were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? no.Did the patient undergo an mri since device implant? if so, when was the mri and what strength? unknown.Did the patient have any other surgeries in the area? no.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.Chest ct in 2018 with intact device.What is the management plan? is device removal scheduled? is a replacement linx or fundoplication planned? plan for device removal.Replacement of linx vs fundoplication tbd.When and if the linx device is removed, may we ask that the device be returned for analysis? yes.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/19/2024.Photo analysis: an x-ray image of the device in vivo was reviewed by a medical safety officer.As per medical safety officer: "the image demonstrates a linx device that appears to be discontinuous and may be located above the diaphragm." the mechanism/cause of failure is unknown as a hands-on analysis of the device is necessary to determine the cause of failure.No further investigation can be completed at this point.The device lot number is unknown; therefore, the device history record could not be reviewed.Additional information received: when was the initial linx implanted? (b)(6) 2017.When was the device explanted? not yet explanted.Were dilations performed? no.Was there any hiatal or rural repair done at the same time as the implant? yes.Were there any other contributing factors that led to the removal of the device other than the reported dysphagia? recurrent cough.What was the reason for removal of the linx device? broken device.When using the linx sizing device what technique was used to determine the size ( i.E.Pop plus 2 or pop plus 3 ) not documented.Did the patient have an autoimmune disease? no.Is the patient currently taking steroids / immunization drugs? no.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? no.How severe was the dysphagia/odynophagia before intervention? no.Were there any intra-operative complications during implant? no.Was there any hiatal or rural repair done at the same time as the implant? yes.Was the device found in the correct position/geometry at the time of removal? unknown.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.

• Brand Name: 1.5T LINX, 13B
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4545 creek road; cincinnati OH
• Manufacturer Contact: kate karberg ; 4545 creek rd.; cincinnati, OH 45242 ; 3035526892
• MDR Report Key: 19142179
• Report Number: 3008766073-2024-00068
• Device Sequence Number: 18122887
• Product Code: LEI
• UDI-Device Identifier: 00855106005332
• UDI-Public: 00855106005332
• 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: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2024

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: LXMC13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown