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

Catalog Number	3501625
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	02/04/2025
Type of Reportable Event	Serious Injury
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.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.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 breast augmentation revision surgery with implantation of a 200cc mentor smooth round moderate profile saline breast implant prosthesis.Post-operatively, the patient was diagnosed with a deflated left breast implant using ultrasound imaging.As a result, the patient underwent left breast removal and replacement with a 250cc mentor smooth round moderate profile saline breast implant on (b)(6) 2025.
Additional Manufacturer Narrative
On may 19, 2025, mentor completed an evaluation on an image that was provided of the suspect medical device.Upon visual evaluation of the image provided in the complaint, the implant was observed deflated.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On june 26, 2025, the mentor analysis lab received the suspect medical device for evaluation.Paperwork received with the device provided a patient identifier.Patient identifier: k.S.Y.On (b)(6) 2025, mentor completed an evaluation on the returned device.Device evaluation: mentor then conducted visual inspection and microscopic examination of the device.Visual analysis of the returned device, determined that the breast implant was found to be deflated.Two tears were found, one (a) on the anterior view, and the second tear (b) on the posterior view, measuring approximately 5.0 cm, and 1.5 cm, respectively.Microscopic examination was performed on the edges of the tears (a and b), and parallel striations were found in an area of both tears, measuring approximately less than 0.1 cm.Parallel striations are consistent with markings made by a sharp object perforating the implant shell.The cause in the remaining area of the tears could not be identified.Manufacturer¿s reference number: (b)(4).

• 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: 22005996
• Report Number: 1645337-2025-05116
• Device Sequence Number: 9099797
• Product Code: FWM
• UDI-Device Identifier: 00081317001201
• UDI-Public: (01)00081317001201(17)150331(10)6457225
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• 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: 03/31/2015
• Device Catalogue Number: 3501625
• Device Lot Number: 6457225
• 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: 04/21/2025
• Supplement Date Received by Manufacturer: 05/19/2025; 06/26/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/06/2025; 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2011
• 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 Sex: Female