BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 10516667 · Received September 10, 2020

    Report

    Report Number
    1645337-2020-11338
    Event Type
    Injury
    Date Received
    September 10, 2020
    Date of Event
    July 28, 2020
    Report Date
    August 20, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000709
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020, DURING VISUAL EVALUATION OF THE DEVICE NO APPARENT DAMAGE OR ANOMALIES WERE OBSERVED. LEAK TESTING WAS PERFORMED, ACCORDING WITH MENTOR PROCEDURE, AND IT REVEALED A TEAR WITHIN THE SILTEX CRACKING MEASURING APPROXIMATELY 0.2 CM IN THE POSTERIOR VIEW. 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. A SECOND PRODUCT WAS RECEIVED. NO ADVERSE EVENTS WERE REPORTED FOR THIS CONCOMITANT (CONTRALATERAL) DEVICE, THEREFORE NO FURTHER ANALYSIS IS REQUIRED. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS LOT. EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. RUPTURE COMPLAINT INFORMATION IS CONSISTENTLY ANALYZED AND MONITORED BY MENTOR QUALITY ASSURANCE TO DETERMINE WHEN FURTHER ACTION IS NECESSARY. 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 (B)(6) 2020, A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 150428, AND NO NON-CONFORMANCE'S RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. 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: RUPTURE. MEDICAL DEVICE REMOVAL. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL BREAST IMPLANT 375CC AND EXPERIENCED RUPTURE ON THE RIGHT BREAST IMPLANT. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 375CC ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979637 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3543757 150428 00081317000709

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention