BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 17270888 · Received July 6, 2023

    Report

    Report Number
    1645337-2023-07946
    Event Type
    Injury
    Date Received
    July 6, 2023
    Date of Event
    May 11, 2023
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001232
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON SEPTEMBER 7, 2023, MENTOR RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE PATIENT'S IMPLANT WAS REPLACED WITH A 375CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE (CATALOG: 3501660 LOT: 9781857 SN: (B)(6)).

    Additional Manufacturer Narrative · 0

    ON JULY 28, 2023, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE PATIENT IDENTIFIER WAS ALSO PROVIDED. ON AUGUST 7, 2023, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR THEN CONDUCTED A VISUAL INSPECTION, MICROSCOPIC EXAMINATION, AND THICKNESS MEASUREMENT OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE SAL SMOOTH RND DIAP 275CC BREAST IMPLANT WAS FOUND TO BE RUPTURED. THE RUPTURE EXTENDED APPROXIMATELY 2.3 CM FROM THE POSTERIOR TO THE ANTERIOR VIEW. MICROSCOPIC EXAMINATION WAS PERFORMED AND THE CAUSE OF THE DEFLATION COULD NOT BE IDENTIFIED. THEREFORE A THICKNESS MEASUREMENT WAS CONDUCTED ON THE SHELL AT THE TEAR, AND THE THICKNESS WAS WITHIN MANUFACTURING SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. ALTHOUGH NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED EVENT, THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING CAUTION: CAUSES OF DEFLATION OF SALINE IMPLANTS INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING EVENTS: CREASE FOLD FAILURE, INTRAOPERATIVE OR POSTOPERATIVE TRAUMA, EXCESSIVE STRESSES OR MANIPULATIONS AS MAY OCCUR DURING NORMAL, DAILY ROUTINES INCLUDING CUSTOMARY AND PURPOSEFUL TRAUMA SUCH AS THAT WHICH CAN OCCUR DURING VIGOROUS EXERCISE, ATHLETICS, ETC. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. CAPA ACTIVITY WAS NOT REQUIRED.

    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. 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. AN ANALYSIS OF THE SUSPECT MEDICAL DEVICE'S PHOTO WAS COMPLETED. INVESTIGATION SUMMARY: UPON VISUAL EVALUATION OF THE IMAGE PROVIDED IN THE COMPLAINT, THE IMPLANT WAS OBSERVED DEFLATED. AS THE PRODUCT INVOLVED IN THIS COMPLAINT WAS NOT RECEIVED, THE DEVICE COULDN´T BE ANALYZED ACCORDING TO OUR PROCEDURES. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. AS PART OF MENTOR¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. CAPA ACTIVITY WAS NOT REQUIRED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST AUGMENTATION WITH A 275CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA ULTRASOUND, WITH LEFT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421824 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3501640 6521092 00081317001232

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention