MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 15B; ANTI-REFLUX IMPLANT

Catalog Number	LXMC15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heartburn/Indigestion (1883)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4); date sent; 2/13/2024.B3: only event year known: 2024.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.Lot number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Additional information was requested, and the following was obtained: lot 28780.After implant, was the device initially effective in controlling reflux? yes.Implant took place (b)(6) 2022.When did the recurrent reflux begin? patient reported recurrent symptoms during visit on (b)(6) 2022.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 patient has recurrent reflux.Postsurgical changes without residual or recurrent hernia ph bravo- patient spent 10.7% of time in reflux with 110 acid reflux episodes and composite demeester score 32.7.Testing did not reveal discontinued linx device.The patient did not undergo any mri.
Additional Manufacturer Narrative
(b)(4), date sent: 2/22/2024.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/15/2024.Investigation summary: a washer was noted, to be disconnected from a clasp bead.The washer was observed, to be bent outwards and weld tracks are visible on both the washer and clasp bead.These findings suggest, that the washer was pulled out of the clasp bead, due to external forces applied, during an explant procedure.The remaining device characteristics, excepting the issues called out above, show no anomalies for a device that has been reasonably changed.As part of the explant procedure and tooling marks were noted, in some beads and washer.Link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.A manufacturing record evaluation was performed, for the finished device 28780 number.And no non-conformances related to the malfunction were identified.

• Brand Name: 1.5T LINX, 15B
• 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: 18697497
• Report Number: 3008766073-2024-00031
• Device Sequence Number: 8424139
• 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 Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 03/15/2024

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 Expiration Date: 06/29/2025
• Device Catalogue Number: LXMC15
• Device Lot Number: 28780
• 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: 01/31/2024
• Supplement Date Received by Manufacturer: 02/16/2024; 03/15/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 02/22/2024; 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2021
• 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 Age: 61 YR
• Patient Sex: Male
• Patient Weight: 102 KG