MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	3505430BC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Breast Discomfort/Pain (4504)
Date of Event	12/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on april 23, 2025.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: breast pain.Device evaluation summary: during visual evaluation, no apparent damage or visual anomalies were observed on the returned device.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: since no malfunction was observed during the investigation.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).
Event or Problem Description
It was reported that a patient who underwent primary breast augmentation with 430cc mentor memorygel breast implants experienced right sided rupture and bilateral breast pain post procedure.The rupture was thought to have been caused by a car accident.As a result, replacement with mentor gel was performed.The right sided rupture was reported initially under 1645337-2025-00705.On april 2, 2025, mentor received additional information and initial awareness of bilateral issues.This report relates to the left prosthesis.

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• 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: 21914039
• Report Number: 1645337-2025-04434
• Device Sequence Number: 7266888
• Product Code: FTR
• UDI-Device Identifier: 00081317006954
• UDI-Public: (01)00081317006954(17)260602(10)9582882
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/02/2026
• Device Catalogue Number: 3505430BC
• Device Lot Number: 9582882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2021
• 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 Age: 38 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White