MAUDE Adverse Event Report: MENTOR TEXAS SM MPPS DV 500CC; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	3502500
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient implanted with a 500cc mentor smooth round moderate plus profile saline breast prosthesis experienced a deflation on the right side post-operatively.As a result, the patient underwent explantation on (b)(6) 2025.
Additional Manufacturer Narrative
Device evaluation summary: since no serial number was available on the returned devices, it was not possible to determine which device corresponded to the right-side breast implant, therefore, both products were analyzed.The device b was returned to mentor for evaluation.Mentor then conducted a visual inspection, leak testing, and microscopic examination of the returned device.Visual analysis of the returned device revealed that no damage or anomalies were observed on the sm mpps dv 500cc breast implant.Leak testing was performed, in accordance with mentor procedures, and it identified two tears on the posterior view, measuring both approximately 0.1 cm.In addition, no other leak sites were detected during the analysis.Microscopic examination was performed on the edges of the ruptures, and parallel striations were found in the whole area of both tears (a and b).Parallel striations are consistent with markings made by a sharp object perforating the implant shell.Based on the information currently available, microscopic examination of the returned product indicates that the implant could have been damaged during or subsequent to implantation.The product insert data sheet cautions to not allow cautery devices or sharp instruments, such as scalpels, suture needles, hypodermic needles, hemostats, adson forceps or scissors to contact the device during the implantation or other surgical procedures.As part of mentor's quality process, all devices are manufactured, inspected, and released according to approved specifications.Based on the results of this investigation, it was determined that the product met the manufacturing release criteria: no corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Manufacturer¿s reference number: (b)(4).

• Brand Name: SM MPPS DV 500CC
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: henry boden ; 3041 skyway circle north; irving, TX 75038 ; 9497882078
• MDR Report Key: 22373099
• Report Number: 1645337-2025-07177
• Device Sequence Number: 20837334
• Product Code: FWM
• UDI-Device Identifier: 00081317001478
• UDI-Public: (01)00081317001478(17)240819(10)9494114
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/19/2024
• Device Catalogue Number: 3502500
• Device Lot Number: 9494114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2020
• 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
• Patient Age: 51 YR
• Patient Sex: Female