BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TISSUE EXPANDERS

    MDR report key: 22979380 · Received September 5, 2025

    Report

    Report Number
    1645337-2025-09821
    Event Type
    Injury
    Date Received
    September 5, 2025
    Manufacturer
    MENTOR TEXAS
    Product Code
    LCJ
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: N/A. 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).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SMOOTH OPERATOR: NANOTEXTURED BREAST TISSUE EXPANDERS ARE ASSOCIATED WITH LOWER RATES OF CAPSULAR CONTRACTURE. OBJECTIVE/METHODS/STUDY DATA: THE STUDY AIM WAS TO COMPARE THE COMPLICATION PROFILE OF A NEW NANOTEXTURED AND MRI-COMPATIBLE TE TO MICRO- AND MACROTEXTURED TES AND TO IDENTIFY POSSIBLE PREDICTORS FOR COMPLICATIONS. METHODS: A RETROSPECTIVE ANALYSIS OF WOMEN UNDERGOING EXPANDER BASED BREAST RECONSTRUCTION AFTER MASTECTOMY BETWEEN JANUARY 2016 AND MARCH 2022 WAS CONDUCTED. THE PRIMARY ENDPOINT WAS THE DEVELOPMENT OF CAPSULAR CONTRACTURE. A TOTAL OF 147 BREASTS, ENCOMPASSING 82 NANOTEXTURED, 43 MICROTEXTURED AND 22 MACROTEXTURED TES, WERE ANALYZED. PATIENTS WERE STRATIFIED INTO THREE MAIN GROUPS (COHORTS) ACCORDING TO THE SURFACE TEXTURIZATION OF THE USED TE. THIS INCLUDED A NANOTEXTURED COHORT (TE: MOTIVA FLORA®, ESTABLISHMENT LABS, SAN JOSÉ, COSTA RICA, USED FROM 08/2020 ONWARDS), A MICROTEXTURED COHORT (TE: CPX®4 BREAST, MENTOR WORLDWIDE LLC, IRVINE, CA, USA, USED BETWEEN 1/2019 AND 11/2020) AND A MACROTEXTURED COHORT (TE: NATRELLE® 133, ALLERGAN INC., IRVINE, CA, USA, USED BETWEEN 1/2016 AND 12/2018). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED MENTOR DEVICES POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: MENTOR® CPX®4 COMPLICATIONS: SEROMA ¿ 17. INFECTION ¿ 4. HEMATOMA ¿ 4. MASTECTOMY SKIN FLAP NECROSIS ¿ 7. MALPOSITION ¿ 13. BREAST ANIMATION ¿ 4. PAIN ¿ 8. CAPSULAR CONTRACTURE - 36.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264691 UNKNOWN TISSUE EXPANDERS EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other