BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 19262754 · Received May 7, 2024

    Report

    Report Number
    1645337-2024-05379
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    April 4, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001782
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. 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 JUNE 5, 2024, 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. IN ADDITION, THE PATIENT RECEIVED INFORMATION INDICATING THAT THE DEFLATION ACTUALLY HAPPENED ON THE RIGHT BREAST AND THE PATIENT WAS ALSO DIAGNOSED WITH RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN). LASTLY, THE CORRECT SERIAL NUMBER FOR THE REPLACEMENT DEVICE WAS 9981859-044.

    Additional Manufacturer Narrative · 0

    ON JUNE 12, 2024, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR THEN CONDUCTED A VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SAL SILTEX RND DIAP PKG 300CC BREAST IMPLANT WAS FOUND TO HAVE A TEAR ON THE POSTERIOR VIEW, MEASURING APPROXIMATELY 1.0 CM. MICROSCOPIC EXAMINATION WAS PERFORMED AND THE CAUSE OF THE DEFLATION COULD NOT BE IDENTIFIED. 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. MENTOR CONCLUDED THAT THE CAPSULAR CONTRACTURE IN THE PATIENT´S BREAST WAS THE RESULT OF THE BODY´S INDIVIDUAL PHYSIOLOGICAL RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT IN SOFT TISSUE. 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. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS REQUIRED NOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 300CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA PHYSICAL EXAMINATION, WITH LEFT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. THE REPLACEMENT DEVICES WERE: (LEFT) 300CC MENTOR SMOOTH ROUND MODERATE PROFILE CATALOG: 3501645 LOT: 9981859 SN: (B)(6) AND (RIGHT) 300CC MENTOR SMOOTH ROUND MODERATE PROFILE CATALOG: 3501645 LOT: 9981859 SN: (B)(6) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388496 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 6751155 00081317001782

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention