BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 11795122 · Received May 7, 2021

    Report

    Report Number
    1645337-2021-05116
    Event Type
    Injury
    Date Received
    May 7, 2021
    Date of Event
    January 1, 2021
    Report Date
    April 16, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED AND COMPLETED THE EVALUATION OF THE SUSPECT MEDICAL DEVICE. DEVICE EVALUATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SAL SILTEX RND DIAP PKG 350CC BREAST IMPLANT HAD AN AREA OF SILTEX CRACKING ON THE POSTERIOR VIEW. ADDITIONALLY, A TEAR MEASURING APPROXIMATELY 0.5 CM WAS FOUND WITHIN THE SILTEX CRACKING. THE EVALUATION DETERMINED THAT THE CAUSE OF THE DEFLATION IS CONSISTENT WITH NORMAL WEAR. SILTEX CRACKING IS DEFINED AS A MATERIAL SEPARATION OCCURRING IN THE SILTEX LAYER AND CAN EVENTUALLY PROGRESS THROUGH THE SHELL OF SILTEX DEVICES. SILTEX CRACKING IS ULTIMATELY A RESULT OF HIGH STRESSES. IT SHOULD BE NOTED THAT AS PART OF MENTOR¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 153336 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    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. 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH 350CC TEXTURED MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST IMPLANTS EXPERIENCED RIGHT-SIDED IMPLANT DEFLATION AND LEFT-SIDED CAPSULAR CONTRACTURE (UNKNOWN GRADE) POSTOPERATIVELY. THE PATIENT PRESENTED WITH LOSS OF VOLUME ON THE RIGHT, AND BREAST SHAPE DISTORTION ON THE LEFT. DIAGNOSES WERE CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE RIGHT-SIDED IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685196 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3542655 153336 00081317001805

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention