MAUDE Adverse Event Report: MENTOR TEXAS SMOOTH MOD HIGH BOOST, 355 CC; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	SMHB355
Medical Device Problem Codes	Material Rupture (1546); Air/Gas in Device (4062)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	12/22/2025
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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: right rupture, and squeaking sound.D4: udi: the expiration date is currently not verified.Therefore, the full udi may be updated accordingly.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 50-year-old caucasian female patient underwent primary breast augmentation with smooth mod high boost, 355 cc and experienced breast implant rupture, and squeaking sound in her right side postoperatively; diagnosed via mri.The patient has consulted with the healthcare professional.As a result, the device was explanted on (b)(6) 2026.
Additional Manufacturer Narrative
Per clinician's review of the additional information received, rupture coding has been removed.Also, year of explant has been correctly updated to 2026 as the device was explanted on (b)(6) 2026.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: right squeaking sound.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On february 10, 2026, the mentor failure analysis lab received the device for evaluation.On february 27, 2026, 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.Sloshing is the audible sound of the breast prosthesis post-implantation.It is self-limiting and does not indicate any deficiency or malfunction of the product and does not cause harm to the patient.The contralateral device was also received (lot number 9918006).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: 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.Manufacturer¿s reference number: (b)(4).

• Brand Name: SMOOTH MOD HIGH BOOST, 355 CC
• 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: 24153103
• Report Number: 1645337-2026-00750
• Device Sequence Number: 13269573
• Product Code: FTR
• UDI-Device Identifier: 10081317031267
• UDI-Public: (01)10081317031267(17)280925(10)9966300
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• 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 Catalogue Number: SMHB355
• Device Lot Number: 9966300
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: 01/26/2026; 02/10/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 02/10/2026; 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2023
• 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: 50 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White