BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 20272096 · Received September 20, 2024

    Report

    Report Number
    1645337-2024-11009
    Event Type
    Injury
    Date Received
    September 20, 2024
    Date of Event
    July 10, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001447
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. 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: 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. 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).

    Additional Manufacturer Narrative · 0

    ON OCTOBER 09, 2024, THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. ON OCTOBER 15, 2024, THE EVALUATION FOR THE DEVICE WAS COMPLETED. DEVICE EVALUATION SUMMARY: VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SM MPPS DV 425CC BREAST IMPLANT HAD A CREASE/FOLD ON THE POSTERIOR VIEW. IN ADDITION, A TEAR WAS NOTED WITHIN THE CREASE MEASURING APPROXIMATELY 0.3 CM. A MICROSCOPIC EXAMINATION WAS PERFORMED AND INSTRUMENT DAMAGE WAS NOT FOUND ON THE AREA OF THE TEAR. THE EVALUATION DETERMINED THAT THE POSSIBLE CAUSE OF THE RUPTURE WAS CONSISTENT WITH NORMAL WEAR. DEFLATION CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. CREATING WRINKLES OR FOLDS SHOULD BE AVOIDED DURING IMPLANTATION OR OTHER PROCEDURES AS IT CAN RESULT IN DEFLATION AT A LATER TIME. BREAST IMPLANTS MAY ALSO SIMPLY WEAR OUT OVER TIME. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A 425CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024 AND REPLACED WITH A 425CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS (CATALOG NUMBER 3502425) WITH LOT NUMBER 9990785.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1668424 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 9525800 00081317001447

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention