BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR MEMORYGEL XTRA BREAST IMPLANT

    MDR report key: 22868514 · Received August 21, 2025

    Report

    Report Number
    1645337-2025-09341
    Event Type
    Malfunction
    Date Received
    August 21, 2025
    Date of Event
    July 1, 2025
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317025160
    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 SEPTEMBER 11, 2025, THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. AFTER FOLLOW UP CLARIFICATION TO CONFIRM THE RETURNED DEVICE INFORMATION, IT WAS DETERMINED THAT THE CORRECT LOT NUMBER FOR THE IMPACTED DEVICE WAS 9994112. 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. 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 · 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. 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: N/A. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE CORRECT DATE OF DEVICE RECEIPT WAS UPDATED TO SEPTEMBER 10, 2025. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON FEBRUARY 15, 2026, THE EVALUATION FOR THE DEVICE WAS COMPLETED. DEVICE EVALUATION SUMMARY: DURING VISUAL EVALUATION NO FOREIGN PARTICLES/HAIR OR VISUAL ANOMALIES WERE OBSERVED ON THE RETURNED DEVICE AND WAS RECEIVED WITHOUT ITS PACKAGING. HOWEVER, A PREVIOUS IMAGE WAS PROVIDED, AND A HAIR ON THE DEVICE IS PERCEIVED. LEAK TESTING WAS PERFORMED, ACCORDING TO MENTOR PROCEDURE, AND NO AREAS OF GEL EXPOSURE WERE FOUND. BASED ON THE INFORMATION CURRENTLY AVAILABLE, A NOTIFICATION WAS SENT TO MENTOR'S MANUFACTURING TEAM FOR FURTHER INVESTIGATION. THE MENTOR MICROBIOLOGY DEPARTMENT PROVIDED THE STERILITY ASSURANCE RECORDS OF THE IMPLANTED DEVICE. THE LOT MET ALL THE STERILIZATION PARAMETERS REQUIRED TO PROVIDE STERILITY ASSURANCE PRIOR TO RELEASE FOR DISTRIBUTION. ACCORDING TO THE MANUFACTURING INVESTIGATION, CONSIDERING THE PROCESS CONTROLS, THE EVALUATION PERFORMED, AND DATA RECORDS REVIEWED FOR THE COMPLAINT DEVICE, THE FOREIGN MATTER (HAIR) REPORTED ON THE PRODUCT COMPLAINT CANNOT BE CONFIRMED AS A MANUFACTURING DEFECT. THE PHYSICAL PRODUCT WAS REQUESTED FOR FURTHER INVESTIGATIONS AND EVALUATIONS, HOWEVER THE DEVICE WAS RECEIVED WITHOUT THE ORIGINAL PACKAGING AND NO FOREIGN PARTICLES/HAIR OR VISUAL ANOMALIES. ANALYSIS WAS PERFORMED USING THE PHOTO PROVIDED BY THE DOCTOR. THIS COMPLAINT CANNOT BE RULED AS A MANUFACTURING DEFECT AS IT CANNOT BE PHYSICALLY CONFIRMED IF THE HAIR CAN BE FOUND INSIDE THE INNER THERMOFORM. 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: NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS REQUIRED NOW. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 685CC MENTOR MEMORYGEL XTRA BREAST IMPLANT WAS FOUND TO HAVE A HAIR BEFORE IT WAS PLACED ON THE FIELD. NO ADVERSE EVENT WAS EXPERIENCED. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419137 MENTOR MEMORYGEL XTRA BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 9994112 00081317025160

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown