BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND SPECTRUM

    MDR report key: 7673282 · Received July 10, 2018

    Report

    Report Number
    1645337-2018-03982
    Event Type
    Injury
    Date Received
    July 10, 2018
    Date of Event
    June 1, 2018
    Report Date
    June 14, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317002024
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MENTOR FAILURE ANALYSIS LAB HAS 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. 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 SMOOTH ROUND SPECTRUM 475CC SALINE BREAST IMPLANT, CATALOG # 3501480, LOT # 211288. (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A SALINE MENTOR SMOOTH ROUND SPECTRUM 475CC AND EXPERIENCED BILATERAL DEFLATION ON BREAST IMPLANTS. THE BREASTS DEFLATION WAS CONFIRMED BY MAMMOGRAM. AS A RESULT, PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH GEL MENTOR MEMORYGEL BREAST IMPLANT 405CC ON (B)(6) 2018. THIS IS FOR THE LEFT SIDE IMPLANT, SEE MANUFACTURER REPORT NUMBER 1645337-2018-03986 FOR CONTRALATERAL PROSTHESIS. THE DEVICE WAS RETURNED TO MENTOR WITHOUT FLUID INSIDE. WHITE MATERIAL WAS OBSERVED WITHIN THE DEVICE. NO FOREIGN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. THE PRODUCT EVALUATION (PE) TEAM DISCOVERED A RENT MEASURING APPROXIMATELY 0.2 CM WITHIN A CREASE ON THE POSTERIOR ASPECT. SEVERAL CREASES WERE NOTICED ON BOTH VIEWS OF THE IMPLANT AS WELL. NO OTHER ANOMALIES WERE DISCOVERED. THE COMPLAINT WAS CONFIRMED SINCE A RUPTURE WAS FOUND ON THE DEVICE. HOWEVER, AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF SUCH DAMAGE OR THE ETIOLOGY OF THE WHITE MATERIAL FOUND ON 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A SALINE MENTOR SMOOTH ROUND SPECTRUM 475CC AND EXPERIENCED BILATERAL DEFLATION ON BREAST IMPLANTS. THE BREASTS DEFLATION WAS CONFIRMED BY MAMMOGRAM. AS A RESULT, PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH GEL MENTOR MEMORYGEL BREAST IMPLANT 405CC ON (B)(6) 2018. THIS IS FOR THE LEFT SIDE IMPLANT, SEE MANUFACTURER REPORT NUMBER 1645337-2018-03986 FOR CONTRALATERAL PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517323 MENTOR SMOOTH ROUND SPECTRUM PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 211288 00081317002024

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention