BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR MEMORYGEL XTRA BREAST IMPLANT

    MDR report key: 21470681 · Received February 26, 2025

    Report

    Report Number
    1645337-2025-02053
    Event Type
    Malfunction
    Date Received
    February 26, 2025
    Date of Event
    January 31, 2025
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317025375
    PMA / PMN Number
    P030053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON OCT 3, 2025, IT WAS DETERMINED A MENTOR MEMORYGEL XTRA BREAST IMPLANT, CATALOG NUMBER SHPX380, LOT NUMBER 9981151 RECEIVED BY THE MENTOR FAILURE ANALYSIS LAB ON SEP 17, 2025, IS THE IMPACTED PRODUCT RELATED TO THIS COMPLAINT. 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 (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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    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. 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. D4: UDI: AS THE LOT/SERIAL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: N/A. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR THEN CONDUCTED VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED DEVICE DETERMINED THAT THE BREAST IMPLANT WAS FOUND TO HAVE A TEAR ON THE ANTERIOR VIEW MEASURING 1.8 CM. MICROSCOPIC EXAMINATION WAS PERFORMED ON THE EDGES OF THE RUPTURE, AND PARALLEL STRIATIONS WERE FOUND IN AN AREA OF THE TEAR ON THE ANTERIOR VIEW, MEASURING APPROXIMATELY 0.2 CM. PARALLEL STRIATIONS ARE CONSISTENT WITH MARKINGS MADE BY A SHARP OBJECT PERFORATING THE IMPLANT SHELL. THE CAUSE OF THE RUPTURE IN THE REMAINING AREA OF THE TEAR COULD NOT BE IDENTIFIED. MENTOR ALSO PERFORMED A MANUFACTURING RECORD EVALUATION RELATED TO THE REPORTED COMPLAINT FOR THE FINISHED DEVICE LOT NUMBER. NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED AS PART OF THIS EVALUATION. AS PART OF MENTOR'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED ACCORDING TO APPROVED SPECIFICATIONS. BASED ON THE RESULTS OF THIS INVESTIGATION, IT WAS DETERMINED THAT THE PRODUCT MET THE MANUFACTURING RELEASE CRITERIA. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MENTOR MEMORYGEL XTRA BREAST IMPLANT 790 CC BEING USED IN A BREAST IMPLANTATION PROCEDURE WAS FOUND TO BE RUPTURED DURING INSERTION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES. THE SURGERY WAS REPORTEDLY DELAYED ABOUT TEN MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595232 MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 9981151 00081317025375

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown