MAUDE Adverse Event Report: AROA BIOSURGERY OVITEX REINFORCED TISSUE MATRIX; SURGICAL MESH

Model Number	F10244-1020P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	03/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced a hernia recurrence approximately 18 months after recurrent ventral hernia repair with ovitex.Upon re-operation it was noted that the device appeared to have torn away from the suture fixation on the perimeter of the device.
Additional Manufacturer Narrative
Without direct assessment of the surgical site, it is not possible to determine whether the suture tore through the patient's tissue or the ovitex device.Further, it was reported that the patient returned to physical activity before the physician recommended date which may have also caused or contributed to this hernia recurrence.

• Brand Name: OVITEX REINFORCED TISSUE MATRIX
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): AROA BIOSURGERY; 2 kingsford smith place; airport oaks, auckland 2022 ; NZ 2022
• MDR Report Key: 16731090
• Report Number: 3010513348-2023-00002
• Device Sequence Number: 6862582
• Product Code: FTM
• UDI-Device Identifier: 09421904065031
• UDI-Public: 09421904065031
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/12/2023
• Report Date (Section F): 04/12/2023

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 Expiration Date: 11/30/2022
• Device Model Number: F10244-1020P
• Device Catalogue Number: F10244-1020P
• Device Lot Number: ERT-9L08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/17/2023
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2023
• 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; Hospitalization
• Patient Sex: Male
• Date Report Sent to FDA: 04/12/2023