BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 20 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 22708270 · Received August 4, 2025

    Report

    Report Number
    9617229-2025-13107
    Event Type
    Injury
    Date Received
    August 4, 2025
    Date of Event
    June 24, 2025
    Report Date
    August 4, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    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 1704837: 692426: BREASTFEEDING DIFFICULTIES. DEVICE NOT RETURNED TO DEVICE ANALYSIS. 696261: BREASTFEEDING DIFFICULTIES. DEVICE NOT RETURNED TO DEVICE ANALYSIS. 1001169: PAIN - NDR, CAPSULAR CONTRACTURE, LUMP/NODULE. DEVICE NOT RETURNED TO DEVICE ANALYSIS. 1080550: CAPSULAR CONTRACTURE, CALCIFICATION - NDR. DEVICE NOT RETURNED TO DEVICE ANALYSIS. THE SEARCH CRITERIA OF THESE QUERIES ARE MENTIONED ON (B)(6). 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 (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.

    Description of Event or Problem · 0

    PATIENT REPORTED "RUPTURE" CONFIRMED VIA MAMMOGRAM AND MRI. THIS RECORD IF FOR LEFT SIDE. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2277418 STYLE 20 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1704837

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention