MAUDE Adverse Event Report: TELA BIO OVITEX PRS; SURGICAL MESH

Model Number	P20163-1620G
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	Fluid Discharge (2686)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A batch record review was conducted which showed no non-conformances or anomalies that may have caused or contributed to this event.The devices were manufactured and sterilized to specification.Wound complications are common events after implant based breast reconstruction with or without the use of surgical mesh.The reported information revealed no potential causes for this event and the root cause could not be determined.
Event or Problem Description
It was reported that ovitex prs (ltr) was implanted on (b)(6) 2024 to reinforce soft tissue during an expander to breast implant exchange procedure.The device was implanted after alloderm had not completely incorporated.After an unknown duration (less than two months), the patient had drainage through the intramammary fold incision.Reoperation was conducted and it was noted that the device had partially resorbed with only the suture material remaining, which was removed.The patient moved to final reconstruction on (b)(6) 2024.

• Brand Name: OVITEX PRS
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): TELA BIO; 1 great valley parkway; suite 24; malvern PA 19355
• Manufacturer Contact: gina nagvajara ; 1 great valley parkway; suite 24; malvern, PA 19355 ; 4844101138
• MDR Report Key: 20568544
• Report Number: 3010513348-2024-00020
• Device Sequence Number: 7873062
• Product Code: FTM
• UDI-Device Identifier: 00810055070183
• UDI-Public: 00810055070183
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K214070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/30/2024

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 Expiration Date: 12/31/2024
• Device Model Number: P20163-1620G
• Device Catalogue Number: P20163-1620G
• Device Lot Number: ERT-24A01
• 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: 10/02/2024
• Initial Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization; Required Intervention
• Patient Sex: Female