MAUDE Adverse Event Report: Mentor Texas MENTOR MemoryGel Xtra Breast Implant; Prosthesis, breast, noninflatable, internal, silicone gel-filled

Catalog Number	SMPX325
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the product was returned to mentor for evaluation where a thorough investigation was conducted.Visual inspection of the returned device determined that some bubbles were observed on the breast implant.In addition, the device was received without its packaging.Leak testing was performed, in accordance with mentor procedures, and it identified a tear on the anterior view, measuring approximately less than 0.1 cm.In addition, no other areas of gel exposure were detected during the analysis.The air could have been passed through the tear and originate the bubbles reported by the customer.Microscopic examination was performed on the edges of the rupture, and parallel striations were found in the whole area of the tear.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 before 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.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.H6 medical device problem code a27: bubbles in gel.Reason for device explant and/or reoperation: n/a.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a mentor memorygel xtra breast implant breast prosthesis had an abnormal appearance.Bubbles were noted in the gel of the device.The issue was discovered prior to surgery, and the device was not implanted in a patient.The device was returned to mentor for analysis and the failure analysis lab discovered that the device was ruptured.

• Brand Name: MENTOR MemoryGel Xtra 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 ; +1(949)788-2078
• MDR Report Key: 50717525
• Report Number: 1645337-2026-10063
• Device Sequence Number: 10586543
• Product Code: FTR
• UDI-Device Identifier: 00081317025030
• UDI-Public: (01)00081317025030(17)300828(10)2120745
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• 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 Catalogue Number: SMPX325
• Device Lot Number: 2120745
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2025
• 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 Sex: Unknown