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

Catalog Number	3502350
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent breast augmentation revision with two 350cc mentor smooth round moderate plus profile saline breast prostheses.Post-operatively, the patient was diagnosed with left breast implant rupture.As a result, the patient underwent breast implant removal and replacement surgery on (b)(6) 2025.The replacement devices were two.
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 (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: material rupture.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).
Additional Manufacturer Narrative
On january 8, 2026, an analysis of the suspect medical device¿s photo was completed.Investigation summary: upon visual evaluation of the image provided in the complaint, the implant was observed deflated.As the product involved in this complaint was not received, the device could not be analyzed according to our procedures.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.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 Manufacturer Narrative
On march 2, 2026, the mentor failure analysis lab received the device for evaluation.The replacement devices were two mentor saline implants.On march 5, 2026, the product investigation was completed.Device investigation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection, leak testing, and microscopic examination of the returned device.During visual analysis of the returned device no apparent damage or visual anomalies were observed.Leak testing was performed in accordance with mentor's procedures.Findings revealed a tear (tear a) on the anterior view, measuring approximately 0.2 cm, also, a second tear (tear b) was identified on the posterior view, between the union of the shell and patch.Microscopic examination was performed on the edges of the tear a, and parallel striations were found in the whole area of the tear a.Parallel striations are consistent with markings made by a sharp object perforating the implant shell.Moreover, microscopic examination was performed and the cause of the deflation on the tear b could not be identified.As the authorization form for examination was not received, the shell thickness on the tear b could not be measured.The evaluation was limited to non-destructive testing.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 tear b in 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.Based on the information currently available, microscopic examination of the tear a in 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 contralateral device was also received (lot number 6524082).The patient did not report any issue with this device.Therefore, no further analysis of the contralateral device is required.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.

• 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: 23918719
• Report Number: 1645337-2025-14397
• Device Sequence Number: 9013123
• Product Code: FWM
• UDI-Device Identifier: 00081317001416
• UDI-Public: (01)00081317001416(17)151130(10)6524082
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• 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: 11/30/2015
• Device Catalogue Number: 3502350
• Device Lot Number: 6524082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 01/08/2026; 03/02/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/24/2026; 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2011
• 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: 54 YR
• Patient Sex: Female