BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMOOTH ROUND MOD. PLUS PROFILE

    MDR report key: 21465359 · Received February 25, 2025

    Report

    Report Number
    1645337-2025-02031
    Event Type
    Injury
    Date Received
    February 25, 2025
    Date of Event
    November 7, 2024
    Manufacturer
    MENTOR MEDICAL SYSTEM B.V.
    Product Code
    FTR
    UDI-DI
    00081317000327
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE. D4: UDI: AS THE SERIAL NUMBER/ LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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 APRIL 10, 2025, AFTER THE DEVICE BEING RETURNED, MENTOR BECAME AWARE THAT THE COMPLAINT DEVICE WAS MANUFACTURED AT THE MENTOR MEDICAL SYSTEMS B.V. FACILITY IN LEIDEN, THE NETHERLANDS. THE DEVICE CATALOG NUMBER HAS BEEN UPDATED TO 350-4001BC AND THE DEVICE LOT NUMBER TO 6915540. MENTOR MEDICAL SYSTEMS B.V, LOCATED IN LEIDEN, THE NETHERLANDS, IS A FOREIGN MANUFACTURER OF MEDICAL DEVICES THAT ARE NOT CLEARED OR APPROVED FOR SALE IN THE US. IT IS A SEPARATE LEGAL ENTITY FROM MENTOR TEXAS. PER 21 CFR 803.58 AND "MEDICAL DEVICE REPORTING FOR MANUFACTURERS" (FDA GUIDANCE DOCUMENT ISSUED ON NOVEMBER 8, 2016), WE ARE ¿[NOT] REQUIRED TO SUBMIT MDR REPORTS FOR EVENTS OCCURRING IN OTHER COUNTRIES FOR A DEVICE THAT IS MANUFACTURED IN A FOREIGN COUNTRY AND THAT IS NOT CLEARED OR APPROVED FOR MARKETING IN THE US. HOWEVER, IF [MENTOR BECOMES] AWARE OF INFORMATION THAT REASONABLY SUGGESTS A DEVICE HAS MALFUNCTIONED AND THAT A SIMILAR DEVICE THAT [IS] MARKETED IN THE US WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR, THEN [MENTOR] SHOULD REPORT THE DEVICE MALFUNCTION THAT OCCURRED OUTSIDE THE US." MENTOR DEVICES DO NOT MEET THE CRITERIA FOR MDR REPORTING AS A SAME OR SIMILAR DEVICE TO A DEVICE THAT IS MARKETED IN THE UNITED STATES. SPECIFICALLY, THE DEVICES DIFFER IN MANUFACTURING PROCESSES AND DEVICE SPECIFICATIONS. SINCE MENTOR MEDICAL SYSTEMS B.V. DO NOT MARKET ANY DEVICES IN THE US, MANUFACTURE & MARKET ALL THEIR DEVICES OUTSIDE THE US, HAVE NEVER HELD FDA APPROVAL NOR CLEARANCE FOR ANY OF THEIR PRODUCTS, AND DO NOT MEET THE CRITERIA FOR REPORTING AS A SAME OR SIMILAR DEVICE, THEIR DEVICES DO NOT MEET THE CRITERIA FOR MDR REPORTABILITY. 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 400CC (LEFT) MENTOR MEMORYGEL BREAST IMPLANT AND A 425CC (RIGHT) MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED BILATERAL RUPTURES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DEVICE EXPLANTATION ON (B)(6), 2025, AND REPLACED WITH MENTOR BREAST PROSTHESES. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327011 SMOOTH ROUND MOD. PLUS PROFILE PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR MEDICAL SYSTEM B.V. 6915540 00081317000327

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Required Intervention