MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX NEXT GEN SIZER; ANTI-REFLUX IMPLANT

Model Number	LST
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a para esophageal hernia repair with msa procedure the magnetic component that normally stands up was laying on the side.They ended up doing repair with a watson instead of a linx.Patient is being kept overnight.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/8/2023.No lot number was provided therefore a device history could not be done.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: why was the patient kept overnight? was this the standard protocol for the procedure or did the patient have to be kept overnight due to the issue during the procedure? please explain more of what is meant by ¿the magnetic component that normally stands up was laying on the side.¿ was there a defect in the linx device that made it unusable? did linx magnetic has any physical damaged that prevents the correct installation? please confirm the product code involved (right now the product code is a lst/ sizer).What is the lot number? were there any patient consequences? if yes, please describe.What was the date of the procedure? what is the current status of the patient? will the device be returning for analysis? 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: LINX NEXT GEN SIZER
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kate karberg ; 4188 lexington avenue north; shoreview ; 3035526892
• MDR Report Key: 16885200
• Report Number: 3008766073-2023-00078
• Device Sequence Number: 6141904
• Product Code: LEI
• UDI-Device Identifier: 10855106005438
• UDI-Public: 10855106005438
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2023

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
• Operator of Device: Health Professional
• Device Model Number: LST
• Device Catalogue Number: LST
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown