BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 15591504 · Received October 12, 2022

    Report

    Report Number
    1645337-2022-12150
    Event Type
    Injury
    Date Received
    October 12, 2022
    Date of Event
    September 20, 2022
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001799
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RIGHT DEFLATION. MENTOR IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH MENTOR HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, MENTOR, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MENTOR, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF CERTAIN INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON NOVEMBER 4, 2022, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. PER DEVICE RECEIVED, LOT NUMBER UNDER FIELD D4 HAS BEEN UPDATED TO "1002829". 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. MENTOR IS AWARE THAT THE DATE OF IMPLANT IS BEFORE THE MANUFACTURE DATE OF LOT 1002829. FOLLOW-UPS ARE IN PROGRESS, AND NO RESPONSE HAS BEEN RECEIVED REGARDING THE DATE. IF ANY CLARIFICATION OR INFORMATION IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ON NOVEMBER 15, 2022, DEVICE EVALUATION WAS COMPLETED. DEVICE EVALUATION SUMMARY: MENTOR CONDUCTED A VISUAL INSPECTION AND LEAK TESTING OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT NO DAMAGE OR ANOMALIES WERE OBSERVED ON THE SAL SILTEX RND DIAP PKG 325CC BREAST IMPLANT. LEAK TESTING WAS PERFORMED, ACCORDING TO THE MENTOR PROCEDURE, AND IT REVEALED A TEAR ON THE ANTERIOR VIEW WITHIN THE SILTEX CRACKING, MEASURING APPROXIMATELY 0.2 CM. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON OCTOBER 26, 2022, MENTOR BECAME AWARE OF THE PRODUCT INFORMATION AND FOLLOWING FIELDS HAVE BEEN UPDATED ON THIS FORM: - BRAND NAME UNDER FIELD D1 HAS BEEN UPDATED TO "MENTOR SILTEX ROUND MODERATE PROFILE" - CATALOG NUMBER UNDER FIELD D4 HAS BEEN UPDATED TO "3542650" - UNIQUE IDENTIFIER( UDI) UNDER FIELD D4 HAS BEEN UPDATED TO (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 54-YEAR-OLD FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST SURGERY WITH UNKNOWN SIZE UNKNOWN SALINE IMPLANTS TEXTURED AND EXPERIENCED BREAST IMPLANT DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY. THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH CATALOG NUMBER 3501650; SERIAL NUMBER (B)(4) ON THE LEFT SIDE, AND WITH CATALOG NUMBER 3501650; SERIAL NUMBER (B)(4) ON THE RIGHT SIDE ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2575090 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3542650 1002829 00081317001799

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention