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

Model Number	VTX5050M
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Torn Material (3024)
Health Effect - Clinical Codes	Hernia (2240); Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, after implantation, centerline mesh fractured months after surgery causing a recurrent hernia.The operative approach was an open procedure - tar.The mesh was cut prior to implantation.Suture was used for the fixation system.There will be an additional surgery to correct the issue.The patient outcome is alive with injury.

• Brand Name: VERSATEX
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 7020609
• Report Number: 9615742-2017-05688
• Device Sequence Number: 16771323
• Product Code: FTL
• Combination Product (Y/N): N
• PMA/510(K) Number: K150091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Type of Report: Initial
• Report Date (Section B): 11/10/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: VTX5050M
• Device Catalogue Number: VTX5050M
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 11/10/2017
• 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: Other