BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 22149242 · Received June 5, 2025

    Report

    Report Number
    9617229-2025-09276
    Event Type
    Injury
    Date Received
    June 5, 2025
    Date of Event
    January 1, 2024
    Report Date
    July 18, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628007338
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    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 INDICATES THAT THERE WERE NO OTHER RECORDS RELATED TO THIS EVENT FOR UNITS MANUFACTURED ON LOT NUMBER 2823688. THE SEARCH CRITERIA OF THESE QUERIES ARE MENTIONED ON QPP07-01- 004-HER1-G02 WORDING GUIDELINES FOR COMPLAINT INVESTIGATION CLOSURE REV 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. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE WAS RECEIVED ON JUNE 24, 2025, WITH LOT NUMBER 2823688. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE: RUPTURE: OBSERVED BROKEN DEVICE ASSESSED AS FOLD FLAW OPENING. AS PER THE INVESTIGATION PROCEDURES, CREASES AND NON-PENETRATING NICKS WERE COMPLETED AND 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 "IMPLANT RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "IMPLANT RUPTURE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51703 INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2823688 10888628007338

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention