BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMOOTH ULTRA HIGH PROFILE

    MDR report key: 23953894 · Received January 4, 2026

    Report

    Report Number
    1645337-2026-00097
    Event Type
    Injury
    Date Received
    January 4, 2026
    Date of Event
    September 18, 2024
    Manufacturer
    MENTOR MEDICAL SYSTEM B.V.
    Product Code
    FTR
    UDI-DI
    00081317000280
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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. LOT 9944664: MANUFACTURING DATE: AUGUST 2, 2023. EXPIRATION DATE: JULY 31, 2028. PRIMARY UDI NUMBER: (B)(4). LOT 9972244: MANUFACTURING DATE: SEPTEMBER 28, 2023. EXPIRATION DATE: SEPTEMBER 26, 2028. PRIMARY UDI NUMBER: (B)(4). REASON FOR DEVICE EXPLANT AND/OR REOPERATION: AS OF NOW THERE IS NO INFORMATION REGARDING THE EXPLANT OR REOPERATION. 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

    PER INFORMATION RECEIVED ON FEBRUARY 23, 2026, MENTOR BECAME AWARE THAT THE DEVICE WAS MANUFACTURED IN LEIDEN. INFORMATION HAS BEEN UPDATED UNDER SECTION D. THE DEVICE REPORTED IN THIS COMPLAINT WAS MANUFACTURED IN LEIDEN, NETHERLANDS. HENCE, DOESN¿T MEET THE CRITERIA FOR MDR REPORTING AND THEREFORE THIS IS THE LAST REPORT THAT WILL BE SUBMITTED. THE LEIDEN BREAST IMPLANTS THAT ARE MANUFACTURED AND DISTRIBUTED UNDER THE MENTOR BRAND BUT ARE NOT APPROVED FOR IMPORT INTO THE UNITED STATES 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. THEREFORE, EVENTS THAT INVOLVE THESE DEVICES WOULD NOT NEED TO BE REPORTED AS MDRS. CORRESPONDING FIELDS HAVE BEEN UPDATED ON THIS FORM. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 300CC MENTOR MEMORYGEL BREAST IMPLANT AND EXPERIENCED UNKNOWN SIDE BREAST IMPLANT RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IMPACTED DEVICE SERIAL NUMBER: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15566 SMOOTH ULTRA HIGH PROFILE PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR MEDICAL SYSTEM B.V. 9521367 00081317000280

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Other