BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 7310138 · Received March 2, 2018

    Report

    Report Number
    1645337-2018-01216
    Event Type
    Injury
    Date Received
    March 2, 2018
    Date of Event
    February 6, 2018
    Report Date
    February 6, 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
    CA, 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. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, 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. CONCOMITANT PRODUCTS: MENTOR SILTEX ROUND MODERATE PROFILE 375CC SALINE PROSTHESIS, CATALOG #3542660, LOT #222799. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON 4/6/2018, MENTOR BECAME AWARE THAT AS A RESULT OF THE RIGHT BREAST PROSTHESIS DEFLATION, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR SILTEX ROUND MODERATE PROFILE 375CC SALINE CATALOG #3542660 LOT #7394549 SN #(B)(4) AND MENTOR SILTEX ROUND MODERATE PROFILE 375CC SALINE CATALOG #3542660 LOT #7394549 SN # (B)(4) ON (B)(6) 2018. DEVICE INVESTIGATION SUMMARY: UPON RECEIPT TO MENTOR, THE DEVICE CONTAINED NO FLUID. YELLOW MATERIAL WAS OBSERVED WITHIN THE DEVICE. YELLOW FOREIGN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. VISUAL EVALUATION OF THE DEVICE REVEALED A RENT MEASURING APPROXIMATELY 0.4CM WITHIN AN AREA SILTEX CRACKING ON THE POSTERIOR ASPECT. NO OTHER ANOMALIES WERE FOUND. 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 OF SUCH DAMAGE OF THE MATERIAL OBSERVED WITHIN THE DEVICE. BECAUSE MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE, PE CONCLUDED THAT THE RENT OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. BASED ON THE INFORMATION PROVIDED, THE PATIENT EXPERIENCED DEFLATION IN THE BREAST IMPLANT. VISUAL EVALUATION OF THE DEVICE REVEALED A RENT MEASURING APPROXIMATELY 0.4 CM WITHIN AN AREA SILTEX CRACKING ON THE POSTERIOR ASPECT. NO OTHER ANOMALIES WERE FOUND. ALL THE IMPLANTS ARE 100% INSPECTED BEFORE LEAVING THE FACILITY. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. 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. THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 222799 WAS REVIEWED 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) -YEAR-OLD FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH A MENTOR SILTEX ROUND MODERATE PROFILE 375CC SALINE PROSTHESIS ON (B)(6) 2001. DEFLATION WAS DIAGNOSED BY A PHYSICIAN ON (B)(6) 2018. AS A RESULT, REPLACEMENT SURGERY IS PLANNED FOR (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153042 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 222799 00081317001812

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention