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
Event or Problem Description
It was reported that a patient required reoperation due to unexpected drainage approximately one month after two stage bilaterial pre-pectoral breast reconstruction with ovitex prs ltr.During reoperation, the surgeon removed the remaining ovitex prs ltr and replaced the tissue expander.
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.It was reported that the device was soaked in a 0.05% chlorhexidine gluconate (chg) solution prior to implantation.The effects of chg on device performance are unknown.Wound complications and reoperations are common events after implant based breast reconstruction.The reported information revealed no potential causes for this event and the root cause could not be determined.

• 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: 21180487
• Report Number: 3010513348-2025-00001
• Device Sequence Number: 8537089
• Product Code: FTM
• UDI-Device Identifier: 00810055070183
• UDI-Public: 00810055070183
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 01/17/2025

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: 01/31/2025
• Device Model Number: P20163-1620G
• Device Catalogue Number: P20163-1620G
• Device Lot Number: ERT-24B01
• 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: 12/19/2024
• Initial Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2024
• 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: IRRISEPT ANTIMICROBIAL WOUND LAVAGE; OVITEX PRS, P20163-1620G, ERT-24C01, EXP 02/28/25
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female