MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS SYMBOTEX; MESH, SURGICAL, POLYMERIC

Model Number	SYM12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extreme Exhaustion (1843); Pain (1994)
Date of Event	11/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter the patient underwent parietal surgery with placement of a 10x15 cm implant of a surgical mesh on (b)(6) 2023, for repair of a 4 mm umbilical hernia.Immediately upon postoperative awakening, the patient experienced severe abdominal pain, which has persisted continuously for over two years.The event resulted in permanent, intolerable pain with significant functional impairment, including profound physical exhaustion, inability to engage in sports or physical activity, loss of social functioning, and marked limitation of activities of daily living.The adverse event has caused a substantial decline in quality of life and psychological well-being and has significantly impaired the patient¿s ability to work; although full-time work was resumed, this required extreme adaptation and is associated with severe pain upon waking, during work, and after returning home, necessitating immediate rest.Medical management includes twice-weekly physiotherapy, twice-monthly osteopathy, with repeated evaluations, and follow-up at a hospital-based chronic pain unit.Despite these interventions, pain relief remains temporary and insufficient, with persistent, debilitating symptoms.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: SYMBOTEX
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24171107
• Report Number: 9615742-2026-00059
• Device Sequence Number: 9578879
• Product Code: FTL
• UDI-Device Identifier: 10884521190344
• UDI-Public: (01)10884521190344(17)271231(10)PXA0182X(20)02
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K142908
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2026

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: SYM12
• Device Catalogue Number: SYM12
• Device Lot Number: PXA0182X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 01/23/2026
• Date Device Manufactured: 01/05/2023
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown