BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 110 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 22375940 · Received July 1, 2025

    Report

    Report Number
    9617229-2025-10960
    Event Type
    Injury
    Date Received
    July 1, 2025
    Report Date
    July 1, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 1469759: 265292: CAPSULAR CONTRACTURE. DEVICE NOT RETURNED TO DEVICE ANALYSIS. 1049973: RUPTURE. DEVICE RETURNED TO DEVICE ANALYSIS. 1981953: RUPTURE AND ANXIETY - PRODUCT/PROCEDURE. DEVICE NOT RETURNED TO DEVICE ANALYSIS. 2370757: PAIN AND ANXIETY - PRODUCT/PROCEDURE. DEVICE NOT RETURNED TO DEVICE ANALYSIS. (B)(4): A0412 MATERIAL RUPTURE. DEVICE NOT RETURNED TO DEVICE ANALYSIS. (B)(4): A0412 MATERIAL RUPTURE. DEVICE NOT RETURNED TO DEVICE ANALYSIS. EVEN THOUGH THERE WERE 4 ADDITIONAL COMPLAINTS OF RUPTURE FOR THIS LOT NUMBER, ONLY 1 DEVICE WAS RETURNED, AND AFTER INSPECTION NO WORKMANSHIPS WERE DETECTED. THE SEARCH CRITERIA FOR THESE QUERIES ARE MENTIONED IN QPP07-01-004-HER1-G02 WORDING GUIDELINES FOR COMPLAINT INVESTIGATION CLOSURE AND 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.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RUPTURE FOUND ON AN MRI AND EXCHANGE OF TEXTURED DEVICES DUE TO PRODUCT CONCERN FOR RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381255 STYLE 110 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1469759

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention