BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 9142499 · Received October 1, 2019

    Report

    Report Number
    1645337-2019-20624
    Event Type
    Injury
    Date Received
    October 1, 2019
    Date of Event
    September 9, 2019
    Report Date
    September 10, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2019, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT. THE EXPLANTATION DATE IS (B)(6) 2019. THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 405CC GEL BREAST PROSTHESES. ON (B)(6) 2019, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: 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. IT WAS INITIALLY REPORTED THAT THE PATIENT¿S LEFT BREAST PROSTHESIS DEFLATED. ADDITIONAL INFORMATION RECEIVED WITH THE RETURNED DEVICES STATES THAT IT WAS THE PATIENT¿S RIGHT BREAST PROSTHESIS THAT DEFLATED AND THE LEFT BREAST PROSTHESIS WAS REMOVED INTACT. -MENTOR RECEIVED BOTH THE PATIENT¿S LEFT AND RIGHT BREAST PROSTHESES. THE LOT NUMBERS FOR THE RETURNED DEVICES ARE 1002769 AND 1010590. IF CLARIFICATION IS RECEIVED ON WHICH OF THESE DEVICES CORRESPONDS TO THE PATIENT¿S DEFLATED RIGHT BREAST PROSTHESIS, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 11/11/2019, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT: THE SUSPECT MEDICAL DEVICE IS A MENTOR SILTEX ROUND MODERATE PROFILE 300CC SALINE BREAST PROSTHESIS, CATALOG #3542645, LOT #1010590, UDI #(B)(4), PMA #(B)(4). 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. IT WAS INITIALLY REPORTED THAT THE IMPLANTATION DATE WAS IN 2013. THE DEVICE MANUFACTURE DATE FOR THE SUSPECT MEDICAL DEVICE IS AFTER THE REPORTED IMPLANTATION DATE ((B)(6) 2004). IMPLANTATION DATE HAS BEEN ESTIMATED TO BE (B)(6) 2004. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2019, MENTOR COMPLETED THE INVESTIGATION ON THE SUSPECT MEDICAL DEVICE. DEVICE EVALUATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, IT WAS REPORTED A PATIENT EXPERIENCED A BREAST IMPLANT DEFLATION. DURING EVALUATION OF THE SAMPLE, IT WAS OBSERVED PARALLEL LINES OF SHELL WEAR RUNNING FROM THE ANTERIOR TO THE POSTERIOR ASPECT. WITHIN A LINE OF SHELL WEAR, A TEAR WAS NOTED MEASURING APPROXIMATELY 0.2 CM IN THE POSTERIOR VIEW. NO OTHER ANOMALIES WERE DISCOVERED. SHELL WEAR FAILURE MAY BE THE RESULT OF THE CONTINUOUS AND SUSTAINED STRESSES TO THE DEVICE. BREAST IMPLANTS ARE NOT CONSIDERED LIFETIME DEVICES AND DEFLATION IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. BASED ON THE INFORMATION REPORTED AND/OR THE PRODUCT INVESTIGATION, THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH THE MANUFACTURING PROCESS. COMPLAINT INFORMATION WILL BE INCLUDED IN COMPLAINT TRENDING THAT IS REVIEWED AND MONITOR BY QUALITY ASSURANCE ON A REGULAR BASIS TO DETERMINE IF FURTHER ACTION IS NECESSARY. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, 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 REVIEW COULD BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH AN UNSPECIFIED MENTOR SALINE BREAST PROSTHESIS THAT DEFLATED AFTER IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT BREAST PROSTHESIS WAS DIAGNOSED BY A HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936584 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 1010590

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other| R