MAUDE Adverse Event Report: Mentor Texas MENTOR Smooth Round Moderate Profile; Prosthesis, breast, inflatable, internal, saline

Catalog Number	3501670
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Breast Cancer (1759); Capsular Contracture (1761); Local Reaction (2035)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a breast reconstruction revision surgery with implantation of a 425cc mentor smooth round moderate profile saline breast implant prosthesis.Post-operatively, the patient was diagnosed with right breast cancer and resultantly underwent partial mastectomy and radiation.After this, she developed right breast capsular contracture (baker grade was not provided) with pain, deformity, and contour deformities.As a result, the patient underwent right-sided exchange with a mentor saline implant on (b)(6) 2025.Additionally, during the surgery, significant inflammation of the capsule and tethering to the skin was observed.Furthermore, oozing was noted from the tissue when dissecting into the implant capsule.
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.D4: udi: product made prior to udi compliance date.Udi not required.Reason for device explant and/or reoperation: capsular contracture, local reaction, breast cancer/partial mastectomy.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).

• 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 ; +1(949)788-2078
• MDR Report Key: 50790981
• Report Number: 1645337-2026-10315
• Device Sequence Number: 21224977
• Product Code: FWM
• UDI-Device Identifier: 00081317001287
• UDI-Public: 00081317001287
• 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: 2001
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial

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: 3501670
• Device Lot Number: 215794
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 53 YR
• Patient Sex: Female
• Patient Race: White