MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SMOOTH ROUND MODERATE PROFILE; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	3501695
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	04/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report was originally submitted on april 25, 2025, but became stuck in ack1 submission status.Per the fda, this issue has been resolved, and this report will now be resubmitted on may 14, 2025, (today) per the fda's request.The product was returned to mentor for evaluation.Mentor conducted a visual inspection, leak testing, and microscopic examination of the device.Visual analysis of the returned device revealed that the breast implant had a crease/fold extending from the anterior to the posterior view.Leak testing was performed, according to mentor procedure, and it identified a tear within the crease/fold on the posterior view, measuring approximately 0.3 cm.A microscopic examination was performed, and instrument damage was not found at the edges of the tear.The evaluation determined that the possible cause of the rupture is consistent with normal wear.Deflation can occur at any time after implantation, but it is more likely to occur the longer the implant is implanted.Creating wrinkles or folds should be avoided during implantation or other procedures, as it can result in deflation at a later time.Breast implants may also simply wear out over time.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.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.Reason for device explant and/or reoperation: deflation manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a primary breast augmentation surgery with implantation of a 625cc mentor smooth round moderate profile saline breast implant prosthesis.Post-operatively, the patient was diagnosed with a deflated left breast implant by a medical professional.As a result, the patient underwent left-sided removal and replacement with a 625cc mentor smooth round moderate profile saline breast implant on (b)(6) 2024.

• Brand Name: MENTOR SMOOTH ROUND MODERATE PROFILE
• 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: 22019319
• Report Number: 1645337-2025-04463
• Device Sequence Number: 9483861
• Product Code: FWM
• UDI-Device Identifier: 00081317001324
• UDI-Public: (01)00081317001324(17)230626(10)7747417
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/25/2025

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: 06/26/2023
• Device Catalogue Number: 3501695
• Device Lot Number: 7747417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2019
• 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 Sex: Female