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

Catalog Number	3502300
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On february 18, 2026, the mentor analysis lab received the suspect medical device for evaluation.On february 25, 2026, mentor completed an evaluation on the returned device.Device evaluation: mentor then conducted visual inspection, leak testing, and microscopic examination of the device.Visual analysis of the returned device revealed that no damage or anomalies were observed on the breast implant.Leak testing was performed, in accordance with mentor procedures, and it identified a tear on the posterior view, measuring approximately 0.1 cm.In addition, no other leak sites were detected during the analysis.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 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.The malfunction identified in the returned device is not related to the malfunction associated to the nonconformance.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: capsular contracture (baker grade i), recall.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.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 300cc mentor smooth round moderate plus profile saline breast implant prosthesis.Post-operatively, the patient was diagnosed with a baker grade 1 capsular contracture and received a recall notice.As a result, the patient underwent bilateral implant removal without replacements on (b)(6) 2025.However, during the surgery, a deflated left implant was discovered.
Additional Manufacturer Narrative
On january 26, 2026, mentor completed a review of the lot history records, and nonconformances were discovered relating to device malfunction.Mentor will address these nonconformances within the quality system.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SMOOTH ROUND MODERATE PLUS 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: 24013007
• Report Number: 1645337-2026-00330
• Device Sequence Number: 9215345
• Product Code: FWM
• UDI-Device Identifier: 00081317001393
• UDI-Public: (01)00081317001393(17)250205(10)9541463
• Combination Product (Y/N): N
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup

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: 02/05/2025
• Device Catalogue Number: 3502300
• Device Lot Number: 9541463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 01/26/2026; 02/18/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 01/29/2026; 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3005423519-10/12/2021-00
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White