BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATERA ABSORBABLE NASAL

    MDR report key: 10665302 · Received October 12, 2020

    Report

    Report Number
    3006345872-2020-00008
    Event Type
    Injury
    Date Received
    October 12, 2020
    Date of Event
    September 21, 2020
    Report Date
    October 16, 2020
    Manufacturer
    ENTELLUS MEDICAL, INC.
    Product Code
    NHB
    PMA / PMN Number
    K161191
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION H6 DEVICE CODE.

    Description of Event or Problem · 0

    ON (B)(6) 2020 THE PATIENT REPORTED VIA THE STRYKER WEBSITE THAT THE LATERA IMPLANT HAD NOT BEEN ABSORBED 2.5 YEARS AFTER IMPLANT AND IS PROTRUDING OUT OF THEIR FACE CAUSING INFECTIONS, HEADACHES AND BREATHING PROBLEMS. ADDITIONAL DETAILS OTHER THAN PATIENT¿S SELF REPORT OF ¿IMPLANT STICKING OF HER FACE, INFECTION, HEADACHES AND BREATHING ONLY GETTING WORSE¿ WERE UNABLE TO BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    IT IS BELIEVED THE LATERA IMPLANT REMAINS IMPLANTED AS NO PRODUCT HAS BEEN RETURNED TO STRYKER FOR ANALYSIS.

    Description of Event or Problem · 1

    ON SEPTEMBER 12, 2020 THE PATIENT REPORTED VIA THE STRYKER WEBSITE THAT THE LATERA IMPLANT HAD NOT BEEN ABSORBED 2.5 YEARS AFTER IMPLANT AND IS PROTRUDING OUT OF THEIR FACE CAUSING INFECTIONS, HEADACHES AND BREATHING PROBLEMS. ADDITIONAL DETAILS OTHER THAN PATIENT¿S SELF REPORT OF ¿IMPLANT STICKING OF HER FACE, INFECTION, HEADACHES AND BREATHING ONLY GETTING WORSE¿ WERE UNABLE TO BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128888 LATERA ABSORBABLE NASAL NHB, LATERA ABSORBABLE NASAL NHB ENTELLUS MEDICAL, INC. LATANI02 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other