BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 20038132 · Received August 22, 2024

    Report

    Report Number
    1645337-2024-09820
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 22, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001492
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 AUGUST 22, 2024, MENTOR RECEIVED ADDITIONAL INFORMATION REGARDING THE DATE OF DEVICE EXPLANTATION. THE DATE OF DEVICE EXPLANTATION WAS UPDATED TO (B)(6) 2024. ON SEPTEMBER 10, 2024, 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON SEPTEMBER 17, 2024, THE EVALUATION FOR THE DEVICE WAS COMPLETED. DEVICE EVALUATION SUMMARY: VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SM MPPS DV 600CC BREAST IMPLANT HAD A CREASE/FOLD ON THE POSTERIOR VIEW. IN ADDITION, A TEAR WAS NOTICED WITHIN THE CREASE/FOLD, MEASURING APPROXIMATELY 0.1 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 IS 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 61-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A 600CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024 AND REPLACED WITH A WITH A MENTOR BREAST PROSTHESIS WITH LOT NUMBER 9924200.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941346 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 9503872 00081317001492

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention