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

Catalog Number LXMC13

Device Problem Protective Measures Problem (3015)

Patient Problem No Code Available (3191)

Event Date 09/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.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.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.What symptoms lead to the discovery of the open device? when did they begin? what was the date of the imaging which showed the discontinuous linx? what is the device lot and serial number? were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? did the patient undergo an mri since device implant? if so, when was the mri and what strength? did the patient have any other surgeries in the area? was the device effective in controlling reflux? 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? was a replacement linx implanted? if no, will the patient eventually have another linx placed? what was the size of the implanted device that was removed (number of beads ¿ product code)?.

Event Description

It was reported that during an unknown procedure, they removed a discontinuous linx this morning.It is unknown if another like device was used to complete the procedure.There were no adverse consequences for the patient reported.

Manufacturer Narrative

(b)(6).Corrected data: this event was reported under 3008766073-2018-00160.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Date sent: 07/23/2020.Additional information received: lxmc13 lot number 8167 and serial number (b)(6).Per photographic evaluation: as per medical safety officer.A review of the abdominal x-ray associated with this compliant was done.The image appeared to be a supine abdominal x-ray.There was an obvious discontinuous linx device seen in the epigastric area.The annular shape was absent and the appearance was c-shape consistent with a discontinuous device.The anatomical location appears consistent with a device placed in the correct position at the cardia.The dhr for lot 8167 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Lot 8167 was an affected lot of the 2018 linx recall.No further investigation can be conducted since the sample was not returned.

Manufacturer Narrative

(b)(4).Date sent: 4/6/2021.The linx device was scanned using micro-focus x-ray computed tomography.The device was received and both ends of the discontinuous device were scanned.Visualization of the internal features was made using this technology.These ct scans produced a digital 3d volume reconstruction that could be analyzed non-destructively.Both ends of the discontinuous device were scanned.Top section: the affected washer through hole of the bead diameter was measured with computed tomography (ct) this washer is within specification.The hole appeared to be round and concentric.The weld ball diameter was measured.This diameter is within specification.There is an interference of approximately 0.004" between the washer through hole and the link weld ball on the link.Bottom section male bead case through hole: the maximum diameter of the male bead case through hole was measured to be in diameter.This is greater than the nominal specification for the through hole and greater than the upper specification limit.The hole appeared round and concentric.The evaluation of the two beads adjacent to the separation in the linx device was conducted using micro-focus ct.This evaluation showed that the diameter of the washer trough hole on the top bead and the weld ball on the link were found to be within dimensional specification.The male bead case through hole was found to be greater than the nominal specification.

Manufacturer Narrative

(b)(4).Date sent: 04/07/2021 h11: corrected data = d4.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 7969836
• MDR Text Key: 123850924
• Report Number: 3008766073-2018-00185
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/27/2018

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 Expiration Date: 05/18/2019
• Device Catalogue Number: LXMC13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Initial Date Manufacturer Received: 09/27/2018
• Initial Date FDA Received: 10/16/2018
• Supplement Dates Manufacturer Received: 11/13/2018; 01/24/2020; 06/29/2020; 01/12/2021; 04/07/2021
• Supplement Dates FDA Received: 11/13/2018; 02/13/2020; 07/23/2020; 04/06/2021; 04/07/2021
• Removal/Correction Number: Z-2038-2018
• Patient Sequence Number: 1