BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAL SILTEX RND DIAP PKG 475CC

    MDR report key: 8647455 · Received May 28, 2019

    Report

    Report Number
    1645337-2019-12606
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    March 18, 2019
    Report Date
    May 1, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001836
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: DURING EVALUATION OF THE SAMPLE A SILTEX CRACKING WAS OBSERVED IN THE POSTERIOR VIEW. LEAK TESTING WAS PERFORMED AND IT REVEALED A TEAR WITHIN THE SILTEX CRACKING, MEASURING APPROXIMATELY 0.03 CM. NO OTHER ANOMALIES WERE OBSERVED. SILTEX CRACKING IS DEFINED AS A MATERIAL SEPARATION OCCURRING IN THE SILTEX LAYER AND CAN EVENTUALLY PROGRESS THROUGH THE SHELL OF SILTEX DEVICES. MENTOR BELIEVES THAT SILTEX CRACKING IS ULTIMATELY A RESULT OF HIGH STRESSES CAUSED BY ACUTE FOLDS (I.E., SEVERE ¿V¿ OR TIGHT FOLDS) IN THE ROOM TEMPERATURE VULCANIZATION (RTV) SHELL OF SILTEX BREAST IMPLANTS. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. NO FURTHER INVESTIGATION WILL BE CONDUCTED ON THIS COMPLAINT AS THERE ARE NO INDICATION THAT THE ISSUE FOUND IS RELATED TO THE MANUFACTURING PROCESS. IT IS MOST LIKELY THAT THE SILTEX CRACKING WAS CREATED DUE OF HIGH STRESSES CAUSED BY ACUTE FOLDS WHICH RESULTING IN A TEAR AT A LATER DATE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    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. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: BILATERAL BREAST IMPLANT DEFLATION 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 REVISION BREAST AUGMENTATION WITH A 475CC MENTOR SILTEX ROUND MODERATE PROFILE AND WAS PRESENTED WITH BILATERAL BREAST IMPLANT DEFLATION CONFIRMED BY THE DOCTOR UPON EXAMINATION ON (B)(6) 2019. AS A RESULT, PATIENT UNDERWENT BILATERAL EXPALNTATION AND REPLACEMENT ON (B)(6) 2019 WITH CATALOG NUMBER 3545107MC; SERIAL NUMBER (B)(4) ON THE RIGHT SIDE AND CATALOG NUMBER 3545557MC; SERIAL NUMBER (B)(4) ON THE LEFT SIDE. THIS REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441599 SAL SILTEX RND DIAP PKG 475CC PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 6449318 00081317001836

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention