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

Catalog Number	3501660D
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	10/27/2025
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.Reason for device explant and/or reoperation: deflation date of explantation: (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. 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 primary breast augmentation surgery with implantation of a 375cc mentor smooth round moderate profile saline breast implant prosthesis.Post-operatively, the patient was diagnosed with a deflated right implant during a physical exam.As a result, the patient was scheduled for breast implant removal on (b)(6) 2025.
Additional Manufacturer Narrative
On january 07, 2026, mentor was notified that the patient was bilaterally replaced with mentor saline implants during the explantation surgery.On january 15, 2026, mentor became aware of updated suspect device information: lot: 2084570.The previously reported serial number does not apply to this device.The serial for this device is unknown.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.On january 23, 2026, the mentor failure analysis lab has 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.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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On march 16, 2026, mentor completed an evaluation on the returned device.Device evaluation: mentor then conducted visual inspection, leak test and microscopic examination of the device.Visual analysis of the returned device revealed that no damage or anomalies were observed on the breast implant.Leak testing was performed, in accordance with mentor procedures, and determine to have two (2) tears on the posterior view.Tear a & b measuring approximately 0.1 cm each.No more leak sites were observed.Microscopic examination was performed on the edges of the rupture, and parallel striations were found in the whole area of the tear.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.The device information has been corrected.The impacted product information was determined to be the following: lot: 2084570.Serial: (b)(6).Corrected data: d4 catalog: 3501660d.D4 primary udi number: (b)(4).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: 23577063
• Report Number: 1645337-2025-12722
• Device Sequence Number: 9641121
• Product Code: FWM
• UDI-Device Identifier: 10081317028977
• UDI-Public: (01)10081317028977(17)290604(10)2084570
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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: 3501660D
• Device Lot Number: 2084570
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 01/07/2026; 03/16/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 01/30/2026; 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2025
• 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: 38 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White