BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMOOTH ROUND MOD. PLUS PROFILE

    MDR report key: 17007071 · Received May 25, 2023

    Report

    Report Number
    1645337-2023-06206
    Event Type
    Injury
    Date Received
    May 25, 2023
    Date of Event
    August 15, 2022
    Manufacturer
    MENTOR MEDICAL SYSTEM B.V.
    Product Code
    FTR
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON JUNE 16, 2023, THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. IT WAS DETERMINED THAT THE COMPLAINT DEVICE WAS MANUFACTURED AT THE MENTOR MEDICAL SYSTEMS B.V. FACILITY IN LEIDEN, THE NETHERLANDS. THE PRODUCT CODE WAS UPDATED TO 350-3751BC. THE LOT NUMBER WAS UPDATED TO 6906316. ON JULY 06, 2023, THE EVALUATION FOR THE DEVICE WAS COMPLETED. DEVICE EVALUATION SUMMARY: DURING THE VISUAL EVALUATION, NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED ON THE SMOOTH ROUND MOD. PLUS PROFILE 375CC RETURNED DEVICE. 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. IT SHOULD BE NOTED THAT 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, CAPA ACTIVITY WAS NOT REQUIRED. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. 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. MENTOR MEDICAL SYSTEMS B.V, LOCATED IN LEIDEN, THE NETHERLANDS, IS A FOREIGN MANUFACTURER OF MEDICAL DEVICES THAT ARE NOT CLEARED OR APPROVED FOR SALE IN THE US. IT IS A SEPARATE LEGAL ENTITY FROM MENTOR TEXAS. PER 21 CFR 803.58 AND "MEDICAL DEVICE REPORTING FOR MANUFACTURERS" (FDA GUIDANCE DOCUMENT ISSUED ON NOVEMBER 8, 2016), WE ARE ¿[NOT] REQUIRED TO SUBMIT MDR REPORTS FOR EVENTS OCCURRING IN OTHER COUNTRIES FOR A DEVICE THAT IS MANUFACTURED IN A FOREIGN COUNTRY AND THAT IS NOT CLEARED OR APPROVED FOR MARKETING IN THE US. HOWEVER, IF [MENTOR BECOMES] AWARE OF INFORMATION THAT REASONABLY SUGGESTS A DEVICE HAS MALFUNCTIONED AND THAT A SIMILAR DEVICE THAT [IS] MARKETED IN THE US WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR, THEN [MENTOR] SHOULD REPORT THE DEVICE MALFUNCTION THAT OCCURRED OUTSIDE THE US." MENTOR DEVICES 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. SINCE MENTOR MEDICAL SYSTEMS B.V. DO NOT MARKET ANY DEVICES IN THE US, MANUFACTURE & MARKET ALL THEIR DEVICES OUTSIDE THE US, HAVE NEVER HELD FDA APPROVAL NOR CLEARANCE FOR ANY OF THEIR PRODUCTS, AND DO NOT MEET THE CRITERIA FOR REPORTING AS A SAME OR SIMILAR DEVICE, THEIR DEVICES DO NOT MEET THE CRITERIA FOR MDR REPORTABILITY. 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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: CAPSULAR CONTRACTURE. 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 FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 375CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 3) POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1618534 SMOOTH ROUND MOD. PLUS PROFILE PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR MEDICAL SYSTEM B.V. 3503751BC 6906316

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention