MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 14B; ANTI-REFLUX IMPLANT

Catalog Number	LXMC14
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 7/15/2024.B3: unknown; captured as awareness date.D6a: exact date is unknown.Assumed first month of the year and first day of the month.A manufacturing record evaluation was performed for the finished device lot number 10039, and no non-conformances were identified.The device is affected by 2018 linx recall product bounding.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 that the facility has a patient who's linx has broken which was confirmed by x-ray.Device has not been explanted.No further information was provided to the sales rep at the time of reporting.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/6/2024.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 discontinuous linx device." 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.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/25/2024 additional information received: the information for the implanted device is lxmc14 10039 (b)(6).She also provided a copy of the imaging which is being attached to the file.I requested the patient history and other details regarding the discontinuous device and will update the file upon receipt.Photo images were received.Any additional information obtained from the photo evaluation will be included as part of the product investigation.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/12/2024.Additional event information: received information from patient that she and her surgeon decided to leave the discontinuous device in place for now.She is not experiencing return of symptoms and so they decided to monitor for one year and ensure the device remains in position and there are no changes in symptomatology.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/13/2025.Additional information received: spoke with (b)(6) in surgeon¿s office who indicated explant procedure has not yet been scheduled as they are still awaiting approval from insurance.She will keep me posted.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/3/2025.Additional information: patient¿s explant has been scheduled for (b)(6) 2025.
Additional Manufacturer Narrative
(b)(4) date sent: 9/17/2025.Additional information received: the explant procedure took place.

• Brand Name: 1.5T LINX, 14B
• 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: 19740157
• Report Number: 3008766073-2024-00103
• Device Sequence Number: 14375045
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: (01)00855106005349(11)160117(17)200117(10)10039
• 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
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/17/2025

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 Expiration Date: 01/17/2020
• Device Catalogue Number: LXMC14
• Device Lot Number: 10039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 07/24/2024; 07/25/2024; 11/06/2024; 02/12/2025; 07/03/2025; 09/17/2025
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 07/25/2024; 08/06/2024; 11/12/2024; 02/13/2025; 07/03/2025; 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2016
• 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
• 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 Sex: Unknown