MAUDE Adverse Event Report: MENTOR TEXAS MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT; EXPANDER, SKIN, INFLATABLE

Catalog Number	SCPX140TH
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Photo evaluation summary: upon visual evaluation of the image provided in the complaint, the expander was observed deflated.As the product involved in this complaint was not received, the device could not be analyzed according to our procedures.Mentor also performed a manufacturing record evaluation related to the reported complaint for the finished device lot number.No manufacturing non-conformance's were identified as part of this evaluation.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 complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.Reason for device explant and/or reoperation: left deflation.D4: udi: as the side and hence, the corresponding serial number for the device involved could not be confirmed, the full udi is currently not available.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 female patient underwent breast surgery with 650cc mentor cpx4 plus, smooth, tall height on both sides and experienced bilateral expander deflation.As a result, the expanders were explanted on (b)(6) 2025.This medwatch report is for the patient¿s left-sided device.
Additional Manufacturer Narrative
On august 22, 2025, photo re-evaluation was completed as follows: upon visual evaluation of the image provided in the complaint, the expander was observed deflated.As the product involved in this complaint was not received, the device could not be analyzed according to our procedures.Mentor also performed a manufacturing record evaluation related to the reported complaint for the finished device lot number.No manufacturing non-conformances were identified as part of this evaluation.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 complaint information monitoring for potential safety signals will be 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).
Additional Manufacturer Narrative
After secondary review of this file performed on september 18, 2025 and verified by the clinician, it was decided to add device problem code "off label use", to more accurately capture the reported event.This supplemental medwatch report is for the patient¿s left-sided device.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT
• 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: 22874423
• Report Number: 1645337-2025-08865
• Device Sequence Number: 10424718
• Product Code: LCJ
• UDI-Device Identifier: 10081317028458
• UDI-Public: (01)10081317028458(17)270313(10)9878987
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• 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: SCPX140TH
• Device Lot Number: 9878987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 08/22/2025; 09/18/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 09/02/2025; 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2023
• 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 Sex: Female