BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMOOTH MOD HIGH BOOST, 775 CC

    MDR report key: 20966979 · Received December 18, 2024

    Report

    Report Number
    1645337-2024-14559
    Event Type
    Injury
    Date Received
    December 18, 2024
    Date of Event
    December 3, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON JANUARY 24, 2025, THE MENTOR FAILURE ANALYSIS LAB 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. ON FEBRUARY 6, 2025, MENTOR BECAME AWARE THAT THE REPLACEMENT SERIAL NUMBERS USED ON (B)(6) 2024 WERE (B)(6) ON THE LEFT SIDE, AND (B)(6) ON THE RIGHT SIDE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON FEBRUARY 12, 2024, DEVICE EVALUATION WAS COMPLETED AS FOLLOWS: MENTOR CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. DURING VISUAL EVALUATION, NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED ON THE SMOOTH MOD HIGH BOOST, 775 CC RETURNED DEVICE. REGARDING THE REPORTED CAPSULAR CONTRACTURE CONDITION, THERE ARE NOT ENOUGH DETAILS TO DETERMINE THE FACTORS THAT MAY HAVE CAUSED THIS CONDITION. CAPSULAR CONTRACTURE IN THE PATIENT¿S BREAST MIGHT BE THE RESULT OF THE BODY¿S INDIVIDUAL PHYSIOLOGICAL RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT IN SOFT TISSUE. FURTHER, CAPSULAR CONTRACTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET THE AMERICAN SOCIETY OF PLASTIC SURGEONS RECOMMENDS AND ENCOURAGES MEMBER SURGEONS TO ALWAYS SUBMIT BREAST IMPLANTS, CAPSULES, AND EFFUSION TO PATHOLOGY FOR EXAMINATION. THE CONTRALATERAL DEVICE WAS ALSO RECEIVED (LOT NUMBER 9971838). THE PATIENT DID NOT REPORT ANY ISSUE WITH THIS DEVICE. THEREFORE, NO FURTHER ANALYSIS OF THE CONTRALATERAL DEVICE IS REQUIRED. AS PART OF MENTOR'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED ACCORDING TO APPROVED SPECIFICATIONS. BASED ON THE RESULTS OF THIS INVESTIGATION, IT WAS DETERMINED THAT THE PRODUCT MET THE MANUFACTURING RELEASE CRITERIA: SINCE NO MALFUNCTION WAS OBSERVED DURING THE INVESTIGATION. 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).

    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: RIGHT CAPSULAR CONTRACTURE; BAKER GRADE III/IV. 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

    IT WAS REPORTED THAT A 45-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 775CC SMOOTH MOD HIGH BOOST DEVICE AND EXPERIENCED CAPSULAR CONTRACTURE; BAKER GRADE III/IV ON HER RIGHT SIDE POSTOPERATIVELY; DIAGNOSED AFTER PHYSICAL EXAM. THE PATIENT HAS CONSULTED WITH THE HEALTHCARE PROFESSIONAL. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2096596 SMOOTH MOD HIGH BOOST, 775 CC PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 9967600

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention