BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 10 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 23498572 · Received November 7, 2025

    Report

    Report Number
    9617229-2025-19256
    Event Type
    Injury
    Date Received
    November 7, 2025
    Date of Event
    October 13, 2025
    Report Date
    January 6, 2026
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628001237
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    LABORATORY ANALYSIS SUMMARY: THE DEVICE RELATED TO THE REPORTED EVENTS RUPTURE WAS RECEIVED ON DECEMBER 09,2025, WITH LOT NUMBER 1770539. 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: NOT OBSERVED THROUGH VISUAL INSPECTION. NONE OF THE OTHER OBSERVATIONS PERFORMED DURING THE DEVICE ANALYSIS (CREASE AND DEFORMATION) ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, AND, THEREFORE, NO FURTHER ACTIONS ARE REQUIRED FOR THESE OBSERVATIONS.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "RUPTURE". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    THE DEVICE WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1923884 STYLE 10 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1770539 10888628001237

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention