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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 09/29/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.No lot number was provided therefore a device history could not be done.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 that a linx device was explanted (b)(6) 2022.No further informaiton was provided.

Manufacturer Narrative

(b)(4).Date sent: 1/20/2023.D6a: exact date unknown.The device was implanted in 2017.First month of year and first day of month is unknown.Additional information received: the implant and explant were done at surgical associates of (b)(6) explanted.It was implanted 2017 due to extreme gerd and a hiatal hernia.

Manufacturer Narrative

(b)(4).Date sent: 2/7/2023 additional information received: spoke with patient who indicated she should receive the lot number information tomorrow and is happy to provide.She wanted a replacement linx device as this device worked well for five years; however, the surgeon indicated he was not comfortable placing around her esophagus at this time.She is controlling symptoms with meds and may revisit a linx in the next couple of years.

Manufacturer Narrative

(b)(4).Date sent: 5/16/2023.Additional information received: patient provided her implant date of (b)(6) 2017; however, she has been unable to locate the lot number for the device.

Manufacturer Narrative

(b)(4).Date sent: 6/29/2023.Investigation summary: a linx device with a visible weld ball that disconnected from a male bead case 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 male bead case at the separation was measured and was greater than the specification.The male bead case was concentric with small amount of material displacement at the outer edge of the through hole.The overall appearance of the surface of the male bead case 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: UNK LINX MAGNETIC IMPLANT
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4545 creek road; cincinnati OH
• Manufacturer Contact: kate karberg ; 4188 lexington avenue north; shoreview ; 3035526892
• MDR Report Key: 15880612
• MDR Text Key: 304472024
• Report Number: 3008766073-2022-00238
• Device Sequence Number: 1
• Product Code: LEI
• 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,Followup,Followup
• Report Date: 06/29/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 11/29/2022
• Supplement Dates Manufacturer Received: 01/06/2023; 01/23/2023; 05/04/2023; 06/28/2023
• Supplement Dates FDA Received: 01/20/2023; 02/07/2023; 05/16/2023; 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention