BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT

    MDR report key: 24807191 · Received April 7, 2026

    Report

    Report Number
    1645337-2026-04100
    Event Type
    Injury
    Date Received
    April 7, 2026
    Date of Event
    October 1, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    LCJ
    UDI-DI
    10081317028373
    PMA / PMN Number
    K182335
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION REVIEW COULD BE PERFORMED. D4: UDI: AS ALL OF THE DEVICE CHARACTERISTICS ARE UNKNOWN AT THIS TIME, THE UDI IS CURRENTLY NOT AVAILABLE. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON APRIL 16, 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. WITH THE RETURNED DEVICE, THE PRODUCT IDENTITY WAS DETERMINED AS THE FOLLOWING: SIZE: 450CC. BRAND NAME: MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT. CATALOG: SCPX127MH. LOT: 9842710. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. D4: UDI: AS THE SERIAL NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION SURGERY WITH IMPLANTATION OF AN UNDISCLOSED MENTOR TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED RIGHT EXPANDER BY A MEDICAL PROFESSIONAL. AS A RESULT, THE PATIENT UNDERWENT RIGHT-SIDED EXCHANGE WITH A MENTOR TISSUE EXPANDER ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537334 MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS 9842710 10081317028373

    Patients

    Seq Age Sex Outcome Treatment
    1