BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIENTRA SILICONE GEL BREAST IMPLANTS

    MDR report key: 20205383 · Received September 12, 2024

    Report

    Report Number
    1651189-2024-07568
    Event Type
    Injury
    Date Received
    September 12, 2024
    Date of Event
    April 10, 2024
    Report Date
    September 5, 2024
    Manufacturer
    SIENTRA INC
    Product Code
    FTR
    PMA / PMN Number
    P070004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SIENTRA COMPLAINT #: (B)(4). AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. SIENTRA WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    SIENTRA COMPLAINT#: (B)(4). SIENTRA RECEIVED THE SUSPECTED DEVICE FROM THE CUSTOMER AND PERFORMED A FAILURE ANALYSIS. THE DEVICE WAS RETURNED WITH SHELL FAILURE AND MODERATE YELLOWING. THE DEVICE WAS UNABLE TO BE WEIGHED. UPON DEVICE INSPECTION, DEVICE RECEIVED IN ONE PIECE. UPON OPTICAL INSPECTION, THIS EXPLANT WAS RECEIVED RUPTURED AND WAS SUBMITTED FOR OPTICAL ANALYSIS. AN UNKNOWN CAUSE WAS IDENTIFIED. THE EXPLANT WAS ANALYZED USING AN OPTICAL MICROSCOPE AND IMAGES WERE TAKEN OF THE AREA AND ARE AS FOLLOWS: 5234057 ANALYSIS 120X 1, 5234057 ANALYSIS 120X 2, 5234097 ANALYSIS 120X 3, AND 5234097 ANALYSIS 120X 4. THE OBSERVED RESULT OF MECHANICAL TESTING WAS 317% FOR ULTIMATE ELONGATION AND 3.5 (LBF) FOR ULTIMATE BREAK FORCE. THE CAUSE OF SHELL FAILURE IS LOCAL STRESS OF UNKNOWN ORIGIN. SIENTRA WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    BILATERAL MALPOSITION, RIGHT SIDE AND RIGHT-SIDE RUPTURE, DISCOVERED DURING SURGERY. RUPTURE DATE OF EVENT: 08/23/2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506341 SIENTRA SILICONE GEL BREAST IMPLANTS SILICONE GEL BREAST IMPLANT FTR SIENTRA INC 20676-XXXE

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention