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

Model Number LXMC14

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 10/13/2020

Event Type  malfunction  

Event Description

Dysfunctional linx with separation.Fda safety report id # (b)(4).

• Brand Name: LINX
• Type of Device: IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
• Manufacturer (Section D): TORAX MEDICAL, INC.
• MDR Report Key: 10699025
• MDR Text Key: 212380612
• Report Number: MW5097316
• Device Sequence Number: 1
• Product Code: LEI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: LXMC14
• Device Lot Number: 13077
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1