BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 10 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 22867409 · Received August 21, 2025

    Report

    Report Number
    9617229-2025-14308
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    November 18, 2024
    Report Date
    October 31, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. DHR TREND SUMMARY: THE REVIEW OF HISTORICAL COMPLAINTS ON THE COMPLAINT MANAGEMENT HANDLING SYSTEM IDENTIFIED THAT THERE WERE OTHER RECORDS FOR UNITS MANUFACTURED ON LOT NUMBER 2251323: 947021: INFECTION, CAPSULAR CONTRACTURE. DEVICE NOT RETURNED TO DEVICE ANALYSIS. (B)(6):A0412 MATERIAL RUPTURE. DEVICE NOT RETURNED TO DEVICE ANALYSIS. EVEN THOUGH THERE WAS 1 ADDITIONAL COMPLAINTS OF RUPTURE FOR THIS LOT NUMBER, THE DEVICE HAS NOT BEEN RETURNED TO CONFIRM THE EVENT OR TO DETECT A POTENTIAL WORKMANSHIP. THE SEARCH CRITERIA OF THESE QUERIES ARE MENTIONED ON QPP07-01- 004-HER1-G02 WORDING GUIDELINES FOR COMPLAINT INVESTIGATION CLOSURE REVISION 6.0 THE REVIEW OF ALL POTENTIAL TREND EVALUATIONS FOR BREAST IMPLANTS CLOSED DURING THE PAST 12 MONTHS INDICATES THAT NO CONFIRMED COMPLAINT TRENDS HAVE BEEN OBSERVED FOR THE EVENT A0412 MATERIAL RUPTURE. 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: DEVICE RUPTURE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, D6B, H6.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: ¿ RUPTURE: OBSERVED OPENING DEVICE ASSESSED AS FOLD FLAW OPENING. AS PER THE INVESTIGATION PROCEDURE CREASES AND STRESS MARKS WERE OBSERVED. NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "RUPTURE" CONFIRMED VIA ULTRASOUND. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2203507 STYLE 10 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2251323

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention