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	08/27/2024
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.Reason for device explant and/or reoperation: breast prosthesis deflation.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.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 breast augmentation revision procedure with mentor smooth round moderate profile 200cc saline breast prostheses that both deflated post implantation.As a result, the patient underwent bilateral explantation and replacement with mentor memorygel xtra breast implant 350cc gel breast prostheses on (b)(6) 2025.This medwatch report is for the patient¿s right breast prosthesis.
Additional Manufacturer Narrative
On 07-mar-2025, mentor completed the investigation on the suspect medical device.The investigation was completed on a photo of the suspect medical device because the physical device has not been received by mentor.Device evaluation summary: according to the information received, the patient experienced a deflation in the breast implant.Upon visual evaluation of the image provided in the complaint, the implant was observed to be 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 complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2025, the mentor failure analysis lab received the device for evaluation.Additionally, a patient identifier (b)(6) was reported.On (b)(6) 2025, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information received, the patient experienced a deflation in the breast implant.The product was returned to mentor for evaluation.Mentor then conducted visual inspection and microscopic examination of the returned device.Visual analysis of the returned device determined that two tears (a and b) were found on the anterior view of the breast implant, measuring approximately 1.2 cm and 0.2 cm respectively.Microscopic examination was performed on the edges of the tears, and parallel striations were found in the whole area of the tears.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.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.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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 21437374
• Report Number: 1645337-2025-01864
• Device Sequence Number: 4683826
• Product Code: FWM
• UDI-Device Identifier: 00081317001201
• UDI-Public: 00081317001201
• 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: 2008
• 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: 10/29/2010
• Device Catalogue Number: 3501625
• Device Lot Number: 5711481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 03/07/2025; 04/01/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 03/14/2025; 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2006
• 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