MAUDE Adverse Event Report: Mentor Texas MENTOR CPX 4 Breast Tissue Expander with Suture Tabs; Expander, skin, inflatable

Catalog Number	3549212
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Type of Reportable Event	Serious Injury

• Brand Name: MENTOR CPX 4 Breast Tissue Expander with Suture Tabs
• 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 ; +1(949)788-2078
• MDR Report Key: 50954108
• Report Number: 1645337-2026-10906
• Device Sequence Number: 10451856
• Product Code: LCJ
• UDI-Device Identifier: 00081317006725
• UDI-Public: (01)00081317006725(17)280729(10)9994844
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 3549212
• Device Lot Number: 9994844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2024
• 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