BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 7231174 · Received January 31, 2018

    Report

    Report Number
    1645337-2018-00617
    Event Type
    Injury
    Date Received
    January 31, 2018
    Date of Event
    December 22, 2017
    Report Date
    January 9, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001812
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: MENTOR SILTEX ROUND MODERATE PROFILE 375CC SALINE PROSTHESIS, CATALOG # 3542660. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON (B)(6) 2018. THE ANALYSIS HAS BEGUN, BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATION AND ANALYSIS HAVE BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 191014 WAS REVIEWED ON (B)(6) 2018 AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED WITH THE FIELD EXPERIENCE REPORT ON 4/12/2018. THE EVENT DATE HAS BEEN UPDATED. WHEN THE DEVICE WAS REMOVED, BILATERAL PROSTHESIS REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 450CC SALINE PROSTHESES. DEVICE EVALUATION SUMMARY: IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX ROUND MODERATE PROFILE 375CC SALINE PROSTHESIS AND EXPERIENCED DEFLATION POST PROCEDURE. UPON RECEIPT TO MENTOR, THE DEVICE CONTAINED NO FLUID. WHITE MATERIAL WAS OBSERVED WITHIN THE DEVICE AND ON THE SHELL SURFACE. VISUAL EVALUATION OF THE DEVICE REVEALED TWO AREAS OF SILTEX CRACKING ON THE POSTERIOR ASPECT. LEAK TESTING WAS PERFORMED IN ACCORDANCE WITH MENTOR PROCEDURES AND REVEALED ONE LEAKAGE; A RENT MEASURING APPROXIMATELY 0.3 CM WITHIN ONE OF THE AREAS OF SILTEX CRACKING ON THE POSTERIOR ASPECT. NO OTHER ANOMALIES WERE FOUND. BECAUSE MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE, THE PRODUCT EVALUATION TEAM CONCLUDED THAT THE RENT AND SILTEX CRACKING OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. THE COMPLAINT WAS CONFIRMED SINCE A RENT WAS FOUND ON THE DEVICE. HOWEVER, AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE EITHER OF SUCH DAMAGE OR OF THE MATERIAL OBSERVED WITHIN THE DEVICE AND ON THE SHELL SURFACE. THERE IS NO EVIDENCE THAT THE FAILURES MODES ARE RELATED WITH MANUFACTURING OR PRODUCT DESIGN. SILTEX CRACKING IS DEFINED AS A MATERIAL SEPARATION OCCURRING IN THE SILTEX LAYER AND CAN EVENTUALLY PROGRESS THROUGH THE SHELL OF SILTEX SALINE-FILLED DEVICES. MENTOR BELIEVES THAT SILTEX CRACKING IS ULTIMATELY A RESULT OF STRESSES CAUSED BY FOLDING OF THE SHELL IN-VIVO. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) -YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX ROUND MODERATE PROFILE 375CC SALINE PROSTHESIS AND EXPERIENCED DEFLATION POST PROCEDURE. AS A RESULT, PROSTHESIS EXPLANT WAS PERFORMED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74445 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 191014 00081317001812

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention