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

Model Number	SYM9F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Micturition Urgency (1871); Pain (1994); Discomfort (2330)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that following an laparoscopic umbilical hernia repair using a composite prosthetic reinforcement, the patient experienced persistent pain and permanent discomfort, included radiating pain from the xiphoid process to the scrotum (right testicle), a white line overhanging the abdominal wall when standing or stretching, discomfort when sitting as if the tip of the xiphoid process pressed on the white line, and the appearance of a flat diamond shape around the xiphoid process suggesting deviation of the upper abdominal muscles from the white line.The patient reported strong discomfort when palpating around the perimeter of the mesh, described as equivalent to a "side stitch," points of pain at the level of the staples, loosening of the abdominal strap, and a persistent bulge at the bottom of the navel.Additional symptoms included increased frequency of sensations of the need to urinate, discomfort during urination, and pain when sitting, especially when the floating ribs contacted the operated area where the prosthesis was located.
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.
Additional Manufacturer Narrative
Correction: g3 (aware date 16jan2026) 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: 24220614
• Report Number: 9615742-2026-00083
• Device Sequence Number: 12783724
• Product Code: FTL
• UDI-Device Identifier: 10884521190641
• UDI-Public: (01)10884521190641(17)291130(10)PYL1086X(20)10
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K220586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2026

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: SYM9F
• Device Catalogue Number: SYM9F
• Device Lot Number: PYL1086X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 02/05/2026
• Date Device Manufactured: 12/18/2024
• 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
• Patient Sex: Unknown