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

Catalog Number LXMC15

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pyrosis/Heartburn (1883); Inflammation (1932)

Event Date 12/28/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 1/18/2024 d6a: exact implant date is unk.Assumed 1st day of the month.No lot number was provided therefore a device history could not be done.Additional information was requested, and the following was obtained: what symptoms lead to the discovery of the discontinuous device? when did they begin? reflux returned / (b)(6) 2023 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 unknown date of imaging ¿ attempting to gain image currently what is the device lot number? unknown was the device initially effective in controlling reflux? yes were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? none reported did the patient undergo an mri since device implant? if so, when was the mri and what strength? no mri did the patient have any other surgeries in the area? none reported 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.Upper gi prior to the explant is a replacement linx or fundoplication planned? device was explanted and no other surgical procedure performed 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 Description

It was reported a linx device was explanted and found to be discontinuous.It was explanted (b)(6) 2023.

Manufacturer Narrative

(b)(4) date sent: 4/10/2024 additional information received; spoke with patient who advised she didn¿t receive a replacement device as her surgeon felt there was too much inflammation at the time of explant.She does not have her device lot number and wasn¿t provided an implant card but knows it was a 1.5 t device.She gave permission for me to follow up with the surgeon to obtain the information.Contacted surgeon to discern if serial/lot number can be ascertained from the implant records.Device lot number is 26275.A manufacturing record evaluation was performed for the finished device 26275 number, and no non-conformances related to the malfunction were identified.

Manufacturer Narrative

(b)(4).Investigation summary: 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, tooling marks were noted in some beads.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 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.

• Brand Name: 1.5T LINX, 15B
• Type of Device: 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: 18538190
• MDR Text Key: 333170522
• Report Number: 3008766073-2024-00011
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2023
• Device Catalogue Number: LXMC15
• Device Lot Number: 26275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 02/28/2024; 03/27/2024
• Supplement Dates FDA Received: 02/28/2024; 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention