BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 23199775 · Received October 2, 2025

    Report

    Report Number
    9617229-2025-16756
    Event Type
    Injury
    Date Received
    October 2, 2025
    Date of Event
    August 1, 2025
    Report Date
    December 16, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    5060191601580
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENTS RUPTURE WAS RECEIVED ON NOV 13, 20205 WITH LOT NUMBER 3142425. PER THE INVESTIGATION PROCEDURE, THE DEVICE IS ANALYZED THROUGH VISUAL INSPECTION MICROSCOPIC INSPECTION IF OPENINGS ARE OBSERVED AND A WEIGHT VERIFICATION. PER THE ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS AND ANY POTENTIAL MANUFACTURING ISSUE ARE DISPLAYED ALONG WITH ANY FURTHER ACTIONS REQUIRED: ¿ RUPTURE: OBSERVED BROKEN DEVICE THROUGH MICROSCOPIC INSPECTION ASSESSED AS UNIDENTIFIED (TEAR) OPENING. NO FURTHER ACTIONS ARE REQUIRED AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. NONE OF THE OTHER OBSERVATIONS PERFORMED DURING THE DEVICE ANALYSIS (MISSING OF ORIENTATION DOTE) ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, AND, THEREFORE, NO FURTHER ACTIONS ARE REQUIRED FOR THESE OBSERVATIONS. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D.9., H.2., H.3., H.6.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A2; A4.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: RUPTURE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "RUPTURED IMPLANT" CONFIRMED WITH ULTRASOUND AND MRI. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. DEVICE HAS BEEN RETURNED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "RUPTURED IMPLANT" CONFIRMED WITH ULTRASOUND AND MRI. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "RUPTURED IMPLANT" CONFIRMED WITH ULTRASOUND AND MRI. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316587 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 3142425 5060191601580

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention