BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    MICROAIRE ENDOTINE

    MDR report key: 11855410 · Received May 20, 2021

    Report

    Report Number
    2020601-2021-00002
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    April 21, 2021
    Report Date
    May 20, 2021
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, LLC
    Product Code
    ODU
    PMA / PMN Number
    K032270
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD ASSOCIATED WITH PART # CFD-22202, LOT # 355991 WAS REVIEWED AND THERE WERE NO ANOMALIES IDENTIFIED WITHIN THE MANUFACTURING PROCESS WHICH WOULD RESULT IN THE REPORTED ISSUE. A REVIEW OF THE DEVICE'S COMPLAINT HISTORY HAS REVEALED THAT THIS PRODUCT IS PERFORMING AS EXPECTED, WITH REGARDS TO THE REPORTED FAILURE MODE. A NURSE WITH THE POSTOPERATIVE AREA STATED THAT THE PATIENT WAS BANGING HER HEAD AGAINST THE SIDE RAIL OF THE BED WHEN SHE WAS WAKING UP FROM THE INITIAL SURGERY THEN THIS MAY HAVE BEEN WHEN THE ENDOTINE DISLODGED. THE BROW DESCENT IS A SECONDARY FAILURE OCCURRING AS A RESULT OF LOSS OF FIXATION WITHIN THE POST/HOLE INTERFACE DUE TO PATIENT ACTIVITY.

    Description of Event or Problem · 1

    ON (B)(6) 2021 THE DOCTOR STATES THAT A (B)(6) YEAR OLD WHITE FEMALE UNDERWENT AN ENDOSCOPIC BROW LIFT WITH LOWER LID BLEPHAROPLASTY AND FAT TRANSPLANT APPROXIMATELY 3 WEEKS AGO. POSTOPERATIVELY, SHE HAD AN ASYMMETRY WITH THE RIGHT SIDE BEING LOWER THAN THE LEFT. SHE HAD THIS PREOPERATIVELY, BUT IT WAS MORE OBVIOUS AND A REVISION SURGERY WAS DISCUSSED TO REENGAGE THE ENDOTINE OR MAKE A NEW FIXATION IN ORDER TO REESTABLISH SYMMETRY OF HER BROW. ON (B)(6) 2021 THE REVISION SURGERY WAS COMPLETED AND THE DOCTOR IDENTIFIED THAT THE INITIAL ENDOTINE IMPLANT WAS DISLODGED FROM THE SURGICAL SITE. ONCE THE DISLODGED IMPLANT WAS REMOVED AND DISCARDED ANOTHER SURGICAL SITE WAS DRILLED AND A NEW ENDOTINE IMPLANT WAS SUCCESSFULLY SEATED AND ADDRESSED THE BROW DESCENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757013 MICROAIRE ENDOTINE ENDOTINE FOREHEAD 3.0 ODU MICROAIRE SURGICAL INSTRUMENTS, LLC CFD-22202 355991

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR