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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 14B; ANTI-REFLUX IMPLANT

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TORAX MEDICAL, INC. 1.5T LINX, 14B; ANTI-REFLUX IMPLANT Back to Search Results
Catalog Number LXMC14
Device Problems Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abscess (1690); Dysphagia/ Odynophagia (1815); Vomiting (2144)
Event Date 10/18/2023
Event Type  Injury  
Manufacturer Narrative
(b)(4).Date sent: 10/30/2023.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 received: prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? yes.On what date did the implant take place? (b)(6) 2019.What is the lot number of the linx device? 24128 / size 14.When using the linx sizing device what technique was used to determine the size? wand using 3 measurement technique.Did the patient have an autoimmune disease? no.Is the patient currently taking steroids / immunosuppressive drugs? no.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? hiatal hernia.How severe was the dysphagia/odynophagia before intervention? patient had three dilations last spring and despite being dilated up to 20 mm and seeing 9 of the beads moving on fluoroscopy he still has the same issue.Were there any intra-operative complications during implant? no was there any hiatal or crural repair done at the same time as the implant? yes, hiatal were there any other contributing factors that led to the removal of the device other than the reported dysphagia? yes, regurgitation daily.Besides the reported dysphagia, what was the reason for removal of the linx device? regurgitation daily was the device found in the correct position/geometry at the time of removal? yes additional information was requested, and the following was obtained: what does the surgeon believe was the cause of the puss noted in the surgery? answer : he could not be certain if it was from mesh, device or previous dilatation.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
A linx was implanted in 2020.The patient recently started experiencing dysphagia had a dilation performed.During surgery abscess were observed with puss.The device was removed.
 
Manufacturer Narrative
(b)(4).Date sent: 12/4/2023.Investigation summary: overall review of the device function and dimensions show no anomalies from a device that has been reasonably changed as part of the explant procedure.Visual analysis was consistent with an explanted device and tooling marks were observed in some beads.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 24128 number, and no non-conformances related to the malfunction were identified.
 
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Brand Name
1.5T LINX, 14B
Type of Device
ANTI-REFLUX IMPLANT
Manufacturer (Section D)
TORAX MEDICAL, INC.
4545 creek road
cincinnati OH
Manufacturer Contact
kate karberg
475 calle c
guaynabo 
3035526892
MDR Report Key18031257
MDR Text Key326912523
Report Number3008766073-2023-00213
Device Sequence Number1
Product Code LEI
UDI-Device Identifier00855106005349
UDI-Public00855106005349
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/04/2023
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? Yes
Device Operator Health Professional
Device Expiration Date11/21/2022
Device Catalogue NumberLXMC14
Device Lot Number24128
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/18/2023
Initial Date FDA Received10/30/2023
Supplement Dates Manufacturer Received11/14/2023
Supplement Dates FDA Received12/04/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/21/2018
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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