BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 11381137 · Received February 25, 2021

    Report

    Report Number
    1645337-2021-02032
    Event Type
    Injury
    Date Received
    February 25, 2021
    Date of Event
    January 14, 2011
    Report Date
    February 5, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001805
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2021, THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 233839 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION ON (B)(6) 2021 , MENTOR THEN CONDUCTED VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT A TEAR WAS FOUND ON THE ANTERIOR ASPECT OF THE SAL SILTEX RND DIAP PKG 350CC BREAST IMPLANT, MEASURING APPROXIMATELY 1.9 CM. MICROSCOPIC EXAMINATION WAS PERFORMED ON THE EDGES OF THE RUPTURE, AND PARALLEL STRIATIONS WERE FOUND IN THE WHOLE AREA OF THE TEAR. PARALLEL STRIATIONS ARE CONSISTENT WITH MARKINGS MADE BY A SHARP OBJECT PERFORATING THE IMPLANT SHELL. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. BASED ON THE INFORMATION CURRENTLY AVAILABLE, MICROSCOPIC EXAMINATION OF THE RETURNED PRODUCT INDICATES THAT THE IMPLANT COULD HAVE BEING DAMAGED DURING OR SUBSEQUENT TO IMPLANTATION. THE PRODUCT INSERT DATA SHEET CAUTIONS TO NOT ALLOW CAUTERY DEVICES OR SHARP INSTRUMENTS, SUCH AS SCALPELS, SUTURE NEEDLES, HYPODERMIC NEEDLES, HEMOSTATS, ADSON FORCEPS OR SCISSORS TO CONTACT THE DEVICE DURING THE IMPLANTATION OR OTHER SURGICAL PROCEDURES. AS PART OF MENTORS QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. MANUFACTURERS REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE OF UNKNOWN TYPE WITH A MENTOR SILTEX ROUND MODERATE PROFILE 350CC AND EXPERIENCED BILATERAL DEFLATION. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 425CC ON (B)(6) 2020. THIS MEDWATCH IS FOR THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274294 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3542655 233839 00081317001805

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention