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

Model Number	DXT1510AR
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Infiltration into Tissue (1931); Pain (1994); Unintended Radiation Exposure (4565)
Date of Event	12/22/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that a patient underwent surgical treatment for a right inguinal hernia, the patient experienced persistent groin pain, abdominal pain, pain radiating to the right testicle and right lumbar fossa, significant constipation tendency, tingling at the level of the prosthesis, a feeling of support at the prosthesis site, throbbing pain with a painful background, increased frequency of urination (10¿12 times/day for 5 days), and traces of blood on a urine strip test.Imaging and clinical suspicion indicated possible migration of the prosthesis, with computed tomography revealing infiltration of fat into the right iliac fossa at the proximal orifice of the right inguinal canal.The patient reported disabling pain as an impact.Pre-existing conditions included fibromyalgia, irritable bowel syndrome, varicocele in the left testicle, cryptorchidism in childhood, and a history of ligamentoplasty of the left ankle.Imaging also identified a 22 mm hepatic cyst.
Additional Manufacturer Narrative
Correction: b5, g3 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.
Event or Problem Description
It was reported that a patient underwent surgical treatment for a right inguinal hernia, the patient experienced persistent groin pain, abdominal pain, pain radiating to the right testicle and right lumbar fossa, significant constipation tendency, tingling at the level of the prosthesis, a feeling of support at the prosthesis site, throbbing pain with a painful background, increased frequencyof urination (10¿12 times/day for 5 days), and traces of blood on a urine strip test.Imaging and clinical suspicion indicated possible migration of the prosthesis, with computed tomography revealing infiltration of fat into the right iliac fossa at the proximal orifice of the right inguinal canal.The patient reported disabling pain as an impact.Pre-existing conditions included fibromyalgia, irritable bowel syndrome, varicocele in the left testicle, cryptorchidism in childhood, and a history of ligamentoplasty of the left ankle.Imaging also identified a 22 mm hepatic cyst.A medication prescribe d take.

• Brand Name: DEXTILE
• 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: 24196442
• Report Number: 9615742-2026-00076
• Device Sequence Number: 10178156
• Product Code: FTL
• UDI-Device Identifier: 10884521726512
• UDI-Public: (01)10884521726512(17)300531(10)SZF0142X(20)10
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K192443
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: DXT1510AR
• Device Catalogue Number: DXT1510AR
• Device Lot Number: SZF0142X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 02/13/2026
• Date Device Manufactured: 06/04/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Sex: Male