MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	3542640
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On december 16, 2025, device evaluation was completed as follows; mentor conducted a visual inspection, and microscopic examination of the returned device.Visual analysis of the returned device revealed that the breast implant was found to have a tear on the posterior view, measuring approximately 1.8 cm.Microscopic examination was performed and the cause of the deflation could not be identified.Mentor also performed a manufacturing record evaluation related to the reported complaint for the finished device lot number.No manufacturing non-conformances were identified as part of this evaluation.Although no conclusion could be reach on the cause of the reported event, the instructions for use contain the following caution: causes of deflation of saline implants include but are not limited to the following events: crease fold failure, intraoperative or postoperative trauma, excessive stresses or manipulations as may occur during normal, daily routines including customary and purposeful trauma such as that which can occur during vigorous exercise, athletics, etc.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.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 61-year-old caucasian female patient underwent primary breast augmentation with 275cc mentor siltex round moderate profile and experienced breast implant deflation on her left side postoperatively; diagnosed after physical exam.The patient has consulted with the healthcare professional.As a result, the patient is scheduled for surgery on (b)(6) 2025.On (b)(6) 2025, the mentor failure analysis lab received the two devices with same lot number engraved and were both found damaged upon evaluation.Hence, this report details investigation results for the second (right side) as malfunction since no issue was reported for the right side.

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• 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: 23818886
• Report Number: 1645337-2025-13942
• Device Sequence Number: 18668079
• Product Code: FWM
• UDI-Device Identifier: 00081317001775
• UDI-Public: 00081317001775
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1998
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• 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: 06/01/2006
• Device Catalogue Number: 3542640
• Device Lot Number: 175107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/1998
• 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: 61 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White