BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND SPECTRUM

    MDR report key: 8051893 · Received November 8, 2018

    Report

    Report Number
    1645337-2018-06714
    Event Type
    Injury
    Date Received
    November 8, 2018
    Date of Event
    February 4, 2018
    Report Date
    October 17, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317002017
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 241045 WAS REVIEWED ON 11/14/2018 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. THE EVALUATION OF THE RETURNED DEVICE WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON 11/20/2018. DEVICE EVALUATION SUMMARY: IT WAS REPORTED THAT A 36-YEAR-OLD FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR SMOOTH ROUND SPECTRUM 425CC SALINE PROSTHESES EXPERIENCED DEFLATION ON THE LEFT BREAST PROSTHESIS POST PROCEDURE, CONFIRMED BY VISUAL EXAMINATION. UPON RECEIPT BY MENTOR, TWO DEVICES WERE RETURNED WITHOUT FLUID. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICES OR ON THE SHELL SURFACES. UPON INITIAL INSPECTION, THE DEVICES APPEARED INTACT. LEAK TESTING WAS PERFORMED IN ACCORDANCE WITH MENTOR PROCEDURES AND NO LEAK SITES WERE DETECTED. NO OTHER ANOMALIES WERE DISCOVERED. BECAUSE THE AUTHORIZATION FOR RETURN AND EXAMINATION OF MEDICAL DEVICE FORM WAS NOT SIGNED AND/OR RETURNED TO MENTOR, THE MENTOR PRODUCT ANALYSIS LAB WAS PRECLUDED FROM FURTHER EVALUATING THE DEVICE. THE COMPLAINT WAS NOT CONFIRMED. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. BECAUSE MENTOR PRODUCT ANALYSIS LAB WAS UNABLE TO CONFIRM ANY UNUSUAL FAILURE MODE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. 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).

    Additional Manufacturer Narrative · 1

    THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 10/26/2018. 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. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: RIGHT MENTOR SMOOTH ROUND SPECTRUM 425CC SALINE PROSTHESIS, CATALOG: 3501470, LOT:236270. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR SMOOTH ROUND SPECTRUM 425CC SALINE PROSTHESES EXPERIENCED DEFLATION ON THE LEFT BREAST PROSTHESIS POST PROCEDURE, CONFIRMED BY VISUAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 375CC GEL PROSTHESES ON (B)(6) 2018; CATALOG # 3505375BC, S/NS (B)(4). THE PATIENT'S CONDITION HAS IMPROVED SINCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892504 MENTOR SMOOTH ROUND SPECTRUM PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 241045 00081317002017

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention