BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 8523009 · Received April 17, 2019

    Report

    Report Number
    1038671-2019-00250
    Event Type
    Injury
    Date Received
    April 17, 2019
    Date of Event
    January 3, 2019
    Report Date
    August 20, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS SPLIT INTO 2 CASES,(B)(4) BECAUSE IT INVOLVED BOTH AN EXACTECH DEVICE AND A BLUEORTHO DEVICE. ACCORDING THE INFORMATION PROVIDED, THE SURGEON NOTICED THE CORACOID WAS BROKEN AFTER HE IMPACTED THE BASEPLATE. A CT SCAN WAS ANALYZED TO DETERMINE IF ANYTHING RELATED TO THE CORACOID ANATOMY AND BONE DENSITY WOULD INDICATE AN INCREASED RISK OF FRACTURE, AND NO INDICATIONS PRESENTED A RISK AHEAD OF THIS PROCEDURE. THE SURGEON SUTURED THE CORACOID BACK TOGETHER AND DOES NOT THINK IT WILL BE AN ISSUE. THE SURGEON REPORTED THE IMPLANT POSITION ON THE POSTOPERATIVE X-RAY WAS SATISFACTORY. BLUE ORTHO SUSPECTS THE TRACKER FIXATION ON THE CORACOID CAUSED THE EVENT. THE FOLLOWING SECTIONS HAVE ADDITIONAL/UPDATED INFO: (G4) DATE RECEIVED BY MANUFACTURER

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION.

    Description of Event or Problem · 1

    CORACOID FRACTURED OCCURRED WHEN IMPACTING THE BASEPLATE. REVERSE SCREWS PUT IN MANUALLY. CORACOID WAS SUTURED BACK TOGETHER. SURGEON DOES NOT THINK IT WILL BE AN ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318556 EQUINOXE BASEPLATE KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention