MAUDE Adverse Event Report: MENTOR TEXAS SMOOTH MOD HIGH BOOST, 545CC; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	SMHB545
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	11/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 33-year-old female patient underwent revision breast augmentation with smooth mod high boost, 545cc on both sides and experienced capsular contracture; baker grade iii on her left side postoperatively; diagnosed after physical exam.The patient has consulted with the healthcare professional.As a result, the patient is scheduled for left side replacement surgery on (b)(6) 2025.It was further reported that the surgery was performed on patient's right side to correct the asymmetry produced by the capsular contracture on the left side.At the time of this report, mentor has received no information regarding explantation or an expected explantation date for the right side.This medwatch report is for the patient¿s left-sided device.
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: left capsular contracture; baker grade iii d6b explanation date: (b)(6) 2025.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).
Additional Manufacturer Narrative
On april 28, 2025, mentor became aware that the left side replacement device used on (b)(6) 2025 was catalog number smhb580; serial number (b)(6).This supplemental medwatch report is for the patient¿s left-sided device.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On may 28, 2025, the mentor failure analysis lab received the device for evaluation.The analysis has begun, but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.This supplemental medwatch report is for the patient¿s left-sided device.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On july 28, 2025, device evaluation was completed as follows: mentor conducted a visual inspection of the returned device.During visual evaluation no apparent damage or visual anomalies were observed on the returned device.Regarding the reported capsular contracture condition, there are not enough details to determine the factors that may have caused this condition.Capsular contracture in the patient¿s breast might be the result of the body¿s individual physiological response to the implantation of a foreign object in soft tissue.Further, capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.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: since no malfunction was observed during the investigation.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.This supplemental medwatch report is for the patient¿s left-sided device.Manufacturer¿s reference number: (b)(4).

• Brand Name: SMOOTH MOD HIGH BOOST, 545CC
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• 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: 21872832
• Report Number: 1645337-2025-03642
• Device Sequence Number: 7864663
• Product Code: FTR
• UDI-Device Identifier: 10081317031151
• UDI-Public: (01)10081317031151(17)281126(10)9980271
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: SMHB545
• Device Lot Number: 9980271
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 04/28/2025; 05/28/2025; 07/28/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 04/30/2025; 06/16/2025; 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2023
• 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: 33 YR
• Patient Sex: Female