BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 120 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 13417618 · Received February 1, 2022

    Report

    Report Number
    9617229-2022-00383
    Event Type
    Injury
    Date Received
    February 1, 2022
    Date of Event
    December 29, 2021
    Report Date
    July 14, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. THE EVENT OF CAPSULAR CONTRACTURE IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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: CAPSULAR CONTRACTURE BAKER GRADE III AND PATIENT'S CONCERN WITH THE PRODUCT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE, ANXIETY, PRODUCT/PROCEDURE AND CAPSULAR CONTRACTURE WAS RECEIVED ON JUNE 22, 2022 WITH LOT NUMBER: 2070889. VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED ONE EXTENDED OPENING AND FOLD CREASES. A WEIGHT TEST OF THE DEVICE WAS VERIFIED AND THE DEVICE UNDERWEIGHT. A MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED ONE OPENING CREASE SHARP, BROKEN STRIATED AND WEAR ABRASION. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: ONE OPENING CREASE SHARP IN THE SIDE RADIUS ASSESSED AS FOLD FLAW OPENING. A STRIATED EDGE BROKEN IN THE SIDE ANTERIOR ASSESSED AS SURGICAL DAMAGE. MISSING SHELL ASSESSED AS INCONCLUSIVE.

    Additional Manufacturer Narrative · 0

    REASON FOR REOPERATION: RUPTURE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" AND "PATIENT'S CONCERN WITH THE PRODUCT" AGAINST LEFT DEVICE. THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III" AND "PATIENT'S CONCERN WITH THE PRODUCT" AGAINST LEFT DEVICE. HEALTHCARE PROFESSIONAL LATER REPORTED RUPTURE. THE DEVICE WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL LATER REPORTED RUPTURE. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496863 STYLE 120 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2070889

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention