BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    MICROAIRE ENDOTINE

    MDR report key: 14856691 · Received June 29, 2022

    Report

    Report Number
    2020601-2022-00002
    Event Type
    Malfunction
    Date Received
    June 29, 2022
    Date of Event
    April 11, 2022
    Report Date
    June 23, 2022
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, LLC
    Product Code
    ODU
    PMA / PMN Number
    K032270
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) ASSOCIATED WITH (B)(6) LOT NUMBER 362265 WAS REVIEWED AND NO ANOMALIES WERE IDENTIFIED WITHIN THE MANUFACTURING PROCESS WHICH WOULD RESULT AND/OR CONTTRIBUTE TO THE REPORTED ISSUE. THIS DEVICE WAS MANUFACTURED ON (B)(6) 2021, PLACED INTO MICROAIRE FINISHED GOODS INVENTORY ON (B)(6) 2021 WITH AN ORIGINAL SHIP DATE OF (B)(6) 2021 TO THIS CUSTOMER. WITHIN THE COMPLAINT INCIDENT REPORT (CIR) IT WAS IDENTIFIED THAT DURING POST OP THE BROW POSITION WAS INITIALLY OKAY BUT WAS LATER NOTICED THAT THE RIGHT BROW DROPPED. THE PATIENT WAS TAKEN BACK INTO SURGERY AND THE RIGHT ENDOTINE HAD DISLODGED FROM THE HOLE AND WAS IN THE SOFT TISSUE. THE IMPLANT WAS REMOVED, A NEW HOLE WAS DRILLED AND A NEW ENDOTINE IMPLANT WAS PLACED AND THE BROW POSITION WAS GOOD. THE COMPLAINT PRODUCT WAS DISCARDED AT THE FACILITY. SINCE THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION MICROAIRE WAS UNABLE TO DETERMINE THE INITIAL CAUSE OF THE IMPLANT FAILURE/DISLODGEMENT OF THE IMPLANT FROM THE SURGICAL SITE AND THE PRIMARY FAILURE WILL BE LISTED AS BROKEN FOR MICROAIRE TRACKING AND TRENDING PURPOSES. THE BROW DESCENT IS A SECONDARY FAILURE OCCURRING AS A RESULT OF LOSS OF FIXATION WITHIN THE POST HOLE INTERFACE.

    Description of Event or Problem · 0

    THE DOCTOR STATED THAT DURING POST OPERATION THE BROW POSITION WAS INTIALLY OKAY BUT THEN THEY NOTICED THAT THE RIGHT BROWN HAD DROPPED. THE PATIENT WAS TAKEN BACK TO SURGERY AND THE RIGHT ENDOTINE IMPLANT HAD COME OUT OF THE HOLE AND WAS IN THE SOFT TISSUE LATERALLY. THIS WAS REMVOED. A NEW HOLE WAS DRILLED, A NEW ENDOTINE WAS PLACED AND THE POST OPERATION BROW POSTION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922800 MICROAIRE ENDOTINE ENDOTINE FOREHEAD 3.0 ODU MICROAIRE SURGICAL INSTRUMENTS, LLC CFD-22202 362265

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female