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

Model Number	P20263-1020G
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	Fluid Discharge (2686)
Date of Event	01/24/2025
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 the events noted.The devices were manufactured and sterilized to specification.The reported information revealed no potential causes for this event and the root cause could not be determined.
Event or Problem Description
A patient underwent bilateral mastopexy with revision augmentation (breast implants were approximately 20 years old) on (b)(6)2024.A partial capsulectomy was performed anteriorly with mentor boost 480cc implants and ovitex prs ltr.On (b)(6)2025 it was noted that the left incision opened with ovitex prs partially resorbed with some polymer remaining.The breast implant was removed with the non-remodeled ovitex prs.A similar event occurred at the right incision on (b)(6)2025.Partial ovitex prs integration was noted on both sides.

• 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: john urtz ; 1 great valley parkway; suite 24; malvern, PA 19355 ; 4843232884
• MDR Report Key: 21472954
• Report Number: 3010513348-2025-00005
• Device Sequence Number: 11610703
• Product Code: FTM
• UDI-Device Identifier: 00810055070770
• UDI-Public: 00810055070770
• 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
• 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): 02/26/2025

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: 01/31/2026
• Device Model Number: P20263-1020G
• Device Catalogue Number: P20263-1020G
• Device Lot Number: ERT-24H07
• 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: 01/31/2025
• Initial Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BREAST IMPLANTS (MENTOR BOOST 480CC)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female