BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIXATOR, ENDOTINE FOREHEAD BIOABSORBABLE 3.5MM

    MDR report key: 11776571 · Received May 4, 2021

    Report

    Report Number
    MW5101159
    Event Type
    Injury
    Date Received
    May 4, 2021
    Date of Event
    April 30, 2021
    Report Date
    May 2, 2021
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS LLC
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ENDOTINE IMPLANT REMOVED; IN (B)(6) 2020, I HAD A LEFT ENDOSCOPIC BROW LIFT PROCEDURE. THE PROCEDURE WENT WELL. WITHIN A FEW WEEKS, I FELT LIKE I HAD MOVEMENT AROUND THE SURGICAL SITE. MY PHYSICIAN¿S OFFICE INDICATED THE ENDOTINES HAD COME UP FROM THEIR IMPLANTED POSITION, WHICH SOMETIMES OCCURRED, BUT THAT THEY WOULD DISSOLVE. IN (B)(6), THE ENDOTINES WERE NOT DISSOLVED, AND I MET WITH MY PHYSICIAN¿S OFFICE AGAIN, AT THIS TIME, WE DETERMINED THAT THEY NEEDED TO BE REMOVED, AND AN APPOINTMENT WAS SCHEDULED. ON (B)(6) 2021 THE LARGEST PIECES OF ENDOTINE, WHICH HAD BROKEN APART AND WERE IMBEDDED IN SCAR TISSUE WERE REMOVED. THE TWO FOLLOWING DAYS, MY FACE AND NECK HAVE BEEN EXTREMELY SWOLLEN, AND THERE HAS BEEN DISCHARGE FROM THE INCISION SITE. THERE IS ALSO A VERY TENDER SPOT IN MY NECK WHICH FEELS VERY SIMILAR TO THE ENDOTINES WHICH WERE IN MY SCALP. THE SWELLING IN MY FACE HAS RADIATED TO THE RIGHT SIDE OF MY FACE, BACK TO MY EAR AND NECK. MY PHYSICIAN IS HIGHLY SKILLED, AND I BELIEVE THIS IS A FAILED ENDOTINE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670833 FIXATOR, ENDOTINE FOREHEAD BIOABSORBABLE 3.5MM SCREW, FIXATION, BONE HWC MICROAIRE SURGICAL INSTRUMENTS LLC 22102 324268

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other| R