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

Catalog Number	UNK LINX MAGNETIC IMPLANT
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The device was received without event details.No patient consequence reported.
Additional Manufacturer Narrative
(b)(4).Date sent:12/13/2023.B3: only event year known: 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: on what date did the implant take place? on what date did the explant take place? lot #? does the patient have any of the allergies to metals? if so, what test have been done to test for metal allergies.Is the patient currently taking currently taking steroids / immunosuppressive drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? was there any hiatal or crural repair done at the same time as the implant? was mesh used at time of implant? what was the reason for removal of the linx device? at the time of removal, was the device found in the correct position/geometry at the time of removal? have the symptoms resolved since the device was explanted? 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.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/2/2024.Additional information received: the product code is a ls13.Additional information was requested, and the following was obtained: on what date did the implant take place? on what date did the explant take place? lot #? does the patient have any of the allergies to metals? if so, what test have been done to test for metal allergies.Is the patient currently taking currently taking steroids / immunosuppressive drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? was there any hiatal or crural repair done at the same time as the implant? was mesh used at time of implant? what was the reason for removal of the linx device? at the time of removal, was the device found in the correct position/geometry at the time of removal? have the symptoms resolved since the device was explanted? no more additional information available.D1, d4.
Additional Manufacturer Narrative
(b)(4) date sent: 1/31/2024 could not be 100% sure that the device was a ls13 d1, d4.
Additional Manufacturer Narrative
(b)(4).Date sent: 2/13/2024.Additional information received: spoke to (b)(6), he stated that he gave the return box to dr.(b)(6) for file (b)(4) a very long time ago.As far as he knew dr.(b)(6) only had 1 device to be returned.Tillman smith has no idea where the other 6 devices came from or how they were sent back under (b)(4).From hcp: all have been explants i performed.Send all my explants back to j&j so they can evaluate the device.They all have a patient name, dob, and mrn on the containers containing the devices.Happy to provide any details if you send me names, dob and mrns.From cg labs: g labs do not have additional information; they sent me the image of the fedex label where they received all the unidentified torax devices.The devices arrived under the (b)(4).Received (2) lxmc17, (2) lxmc16, (2) lxmc14 and (1) lxmc13.A total of 7 blind complaints were created for the returned unidentified devices.
Additional Manufacturer Narrative
(b)(4).Investigation summary: overall review of the device function and dimensions show no anomalies from a device that was returned for analysis.Visual analysis was consistent with an explanted device, and significant tooling marks were noted in some beads.Link length and tensile force were found to meet the applicable specifications.Overall, the device was found to be conforming.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• 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: 18318207
• Report Number: 3008766073-2023-00247
• Device Sequence Number: 6115115
• Product Code: LEI
• UDI-Device Identifier: 00855106005028
• UDI-Public: 00855106005028
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100049
• 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,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/26/2024

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?: No
• Operator of Device: 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 12/14/2023; 01/06/2024; 01/31/2024; 03/25/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 01/02/2024; 01/31/2024; 02/13/2024; 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown