BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATINE FOREHEAD 3.0

    MDR report key: 10247346 · Received July 8, 2020

    Report

    Report Number
    2020601-2020-00004
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Date of Event
    June 5, 2020
    Report Date
    August 12, 2020
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, LLC
    Product Code
    HWC
    UDI-DI
    00847399006882
    PMA / PMN Number
    K060249
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ON JULY 16TH, 2020, MICROAIRE WAS NOTIFIED THAT THE PATIENT ASSOCIATED WITH MDR# 2020601-2020-00004 HAS OPTED NOT TO PURSUE A REVISION SURGERY.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD ASSOCIATED WITH PART# CFD-23202/LOT# 343949 WAS REVIEWED AND THERE WERE NO ANOMALIES IDENTIFIED 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 REGARD TO THE REPORTED FAILURE MODE. MULTIPLE FOLLOW-UPS HAVE BEEN MADE TO THE CUSTOMER FOR INFORMATION RELATED TO THE REPORTED EVENT AND RESULTS OF THE REVISION SURGERY. IF ADDITIONAL INFORMATION IS RECEIVED, THIS RECORD WILL BE UPDATED. WITH THE INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED ISSUE. IT IS POSSIBLE THAT THE SURGEON INADVERTENTLY SHEARED OFF ONE OF THE DEVICE'S COMPRESSION FLANGES BY ATTEMPTING TO IMPLANT IT AT AN OFF-AXIS ANGLE. THIS WOULD RESULT IN INCOMPLETE ANCHORING OF THE DEVICE AND COULD RESULT IN THE DEVICE BECOMING DISLODGED FROM THE HOLE DRILLED FOR IT.

    Description of Event or Problem · 1

    A CUSTOMER HAS REPORTED THAT A PATIENT WAS IMPLANTED WITH ULTRATINE IN (B)(6) 2020. THE PATIENT LATER CONTACTED THE SURGEON TO REPORT THAT THE DEVICE HAD STARTED TO DISLODGE FROM THE HOLE DRILLED FOR IT. A SUBSEQUENT APPOINTMENT HAS BEEN SCHEDULED FOR A POSSIBLE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712687 ULTRATINE FOREHEAD 3.0 ULTRATINE FOREHEAD 3.0 HWC MICROAIRE SURGICAL INSTRUMENTS, LLC CFD-23202 343949 00847399006882

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR