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

Model Number	P20463-2525G
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Codes	Erythema (1840); Skin Inflammation/ Irritation (4545)
Date of Event	10/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent direct-to-implant post mastectomy breast reconstruction on (b)(6) 2025 with breast implants and ovitex prs.The patient experienced post-operative redness and irritation.On (b)(6) 2025 the surgeon performed a reoperation during which a portion of the ovitex prs device was removed.
Additional Manufacturer Narrative
A batch record review showed no nonconformance's or anomalies that may have caused or contributed to this event.The device met all specifications and was sterilized according to validated processes.The root cause could not be established.Additional intervention including surgery is noted in the instructions for use as a possible complication associated with the use of a soft tissue reinforcement device or any soft tissue reinforcement surgical procedure.

• Brand Name: OVITEX PRS
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): TELA BIO, INC.; 1 great valley parkway; suite 24; malvern PA 19355
• Manufacturer (Section G): TELA BIO, INC.; 1 great valley parkway; suite 24; malvern PA 19355
• Manufacturer Contact: john urtz ; 1 great valley parkway; suite 24; malvern, PA 19355 ; 4043202884
• MDR Report Key: 23467555
• Report Number: 3010513348-2025-00017
• Device Sequence Number: 15974727
• Product Code: FTM
• UDI-Device Identifier: 00810055071067
• UDI-Public: 00810055071067
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K243595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 11/04/2025

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: 07/31/2026
• Device Model Number: P20463-2525G
• Device Catalogue Number: P20463-2525G
• Device Lot Number: ERT-25B05
• 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: 10/07/2025
• Initial Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female