MAUDE Adverse Event Report: MENTOR TEXAS MENTOR CPX 4 BREAST TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Catalog Number	3548212
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
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: infection.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 breast augmentation with a 350cc mentor cpx 4 breast tissue expander on the right breast.Post-operatively, the patient suffered right breast infection.As a result, the patient underwent breast implant removal surgery on (b)(6) 2026.
Additional Manufacturer Narrative
On april 6, 2026, the product investigation was completed.Device investigation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection and microscopic examination of the returned device.Visual analysis of the returned device, determined that the tissue expander was found to be deflated.A tear was observed on the posterior aspect measuring approximately 2.5 cm.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 tissue expander shell.Based on the information currently available, microscopic examination of the returned product indicates that the tissue expander 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.Infection, manifested by swelling, tenderness, pain and fever, may appear in the immediate postoperative period or at any time after insertion of the tissue expander.In the absence of classic symptoms, subacute or chronic infections may be difficult to diagnose.If infection does not subside promptly with the appropriate treatment, removal of the tissue expander is indicated.Infection is a known complication associated with any surgery.Per a database query, this is the only reported complaint of infection against this lot number.The mentor microbiology department has provided information on the sterility lot for the implanted device indicating that it met all sterilization parameters required to provide a 10e-6 sterility assurance level prior to release for distribution.Product evaluation concluded the reported infection occurred from a source other than the device.Infection is a known complication associated with any surgery 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: no corrective and preventive action (capa) is required now.
Additional Manufacturer Narrative
On march 11, 2026, 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.

• Brand Name: MENTOR CPX 4 BREAST TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• 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: 24523877
• Report Number: 1645337-2026-02462
• Device Sequence Number: 20961144
• Product Code: LCJ
• UDI-Device Identifier: 00081317006534
• UDI-Public: (01)00081317006534(17)290803(10)2111843
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 3548212
• Device Lot Number: 2111843
• 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: 02/09/2026
• Supplement Date Received by Manufacturer: 03/11/2026; 04/06/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 03/31/2026; 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2025
• 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 Sex: Female