BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND SPECTRUM

    MDR report key: 20526957 · Received October 24, 2024

    Report

    Report Number
    1645337-2024-12498
    Event Type
    Injury
    Date Received
    October 24, 2024
    Date of Event
    August 22, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317002000
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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: MATERIAL RUPTURE, RIPPLING. 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 JANUARY 8, 2025, MENTOR RECEIVED A VIDEO SHOWING A SMALL AMOUNT OF LIQUID OBSERVED AT THE CONNECTOR POINT. ON JANUARY 14, 2025, THE PRODUCT INVESTIGATION SUMMARY WAS UPDATED. THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION, WHERE A VISUAL INSPECTION AND LEAK TESTING OF THE RETURNED BREAST IMPLANT WERE CONDUCTED. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED NO DAMAGE OR ANOMALIES ON THE SPEC SMOOTH RND 375CC BREAST IMPLANT. A LEAK TEST WAS PERFORMED ACCORDING TO MENTOR PROCEDURES, AND NO AREAS OF LEAKAGE WERE DETECTED. ADDITIONAL MANUAL PRESSURE WAS APPLIED TO REPLICATE THE CONDITION SHOWN IN THE PROVIDED VIDEO; HOWEVER, NO LEAK CONDITION WAS FOUND IN THE VALVE SYSTEM. THEREFORE, THE REPORTED LEAK CONDITION COULD NOT BE CONFIRMED, AS THE BREAST IMPLANT WAS RETURNED WITHOUT ANY DETECTABLE DAMAGE. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED ACCORDING TO APPROVED SPECIFICATIONS. SINCE NO MALFUNCTION WAS OBSERVED DURING THE INVESTIGATION, NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS REQUIRED NOW.

    Additional Manufacturer Narrative · 0

    ON FEBRUARY 19, 2025, THE PRODUCT INVESTIGATION SUMMARY WAS UPDATED: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION, WHERE A VISUAL INSPECTION AND LEAK TESTING OF THE RETURNED BREAST IMPLANT WERE CONDUCTED. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED NO DAMAGE OR ANOMALIES ON THE SPEC SMOOTH RND 375CC BREAST IMPLANT. A LEAK TEST WAS PERFORMED ACCORDING TO MENTOR PROCEDURES, AND NO AREAS OF LEAKAGE WERE DETECTED. ADDITIONAL MANUAL PRESSURE WAS APPLIED TO REPLICATE THE CONDITION SHOWN IN THE PROVIDED VIDEO; HOWEVER, THE FAILURE MODE SHOWED IN THE VIDEO PROVIDED COULD NOT BE REPLICATED. THE REPORTED COMPLAINT WAS CONFIRMED BASED ON VIDEO EVIDENCE PROVIDED; HOWEVER, THE ROOT CAUSE COULD NOT BE ESTABLISHED AS THE FAILURE WAS NOT REPLICATED. THE PRODUCT INSERT DATA SHEET STATES THAT WHEN REMOVING THE INJECTION DOME AND FILL TUBE, THE TUBE NEEDS TO BE GRASPED BEYOND THE CONNECTOR AND THE TUBE NEEDS TO BE REMOVED BEFORE TAKING THE INJECTION DOME OUT. DO NOT PULL ON THE CONNECTOR WHILE REMOVING THE TUBE AS IT MAY DISCONNECT, AND SUBSEQUENT DEFLATION COULD OCCUR. USE SLOW AND STEADY TRACTION TO REMOVE THE FILL TUBE AND THUS PREVENT DAMAGE TO THE PROSTHESIS OR ITS SELF-SEALING VALVE. CONTINUE TO PULL FIRMLY ON THE FILL TUBE UNTIL THE ENTIRE LENGTH OF THE TUBE IS WITHDRAWN, WHICH WILL BE EVIDENCED BY A NOTCH IN THE END OF THE TUBE. 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: NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS REQUIRED NOW.

    Additional Manufacturer Narrative · 0

    ON NOVEMBER 14, 2024, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. ON NOVEMBER 19, 2024, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION, THE TUBING, THE CONNECTOR, AND THE INJECTION PORT WERE NOT RETURNED. MENTOR CONDUCTED A VISUAL INSPECTION AND LEAK TESTING OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT NO DAMAGE OR ANOMALIES WERE OBSERVED ON THE SPEC SMOOTH RND 375CC BREAST IMPLANT. LEAK TESTING WAS PERFORMED, IN ACCORDANCE WITH MENTOR PROCEDURES, AND NO LEAKS WERE FOUND FROM THE VALVE SYSTEM. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE BREAST IMPLANT WAS RETURNED WITHOUT LEAKS FROM THE VALVE SYSTEM. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE LABORATORY ANALYSIS. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. SINCE NO MALFUNCTION WAS OBSERVED DURING THE INVESTIGATION, NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS REQUIRED NOW. CORRECTION: THE FOLLOWING INFORMATION WAS ERRONEOUSLY OMITTED FROM THE INITIAL REPORT SENT: THE CAPSULE WAS OPENED WITH CAUTERY AND AN INTACT SALINE IMPLANT WAS REMOVED. WITH COMPRESSION THE VALVE HAD INCOMPETENCE AS SALINE WOULD LEAK FROM THE POSTERIOR VALVE WITH COMPRESSION. MEDICAL DEVICE PROBLEM CODE WAS UPDATED TO CONNECTION PROBLEM (A12).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH TWO 375CC MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH BILATERAL BREAST RIPPLING AND IMPLANT DEFLATIONS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICES WERE: (LEFT) 500CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SMHB500 LOT: 9987904 SN: (B)(6) AND (RIGHT) 500CC MENTOR MEMORYGEL BOOST BREAST IMPLANT CATALOG: SMHB500 LOT: 9991355 SN: (B)(6). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2565142 MENTOR SMOOTH ROUND SPECTRUM PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 9759795 00081317002000

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention