BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURETTE, OPERATIVE

    MDR report key: 6787725 · Received August 11, 2017

    Report

    Report Number
    6787725
    Event Type
    Malfunction
    Date Received
    August 11, 2017
    Date of Event
    August 8, 2017
    Report Date
    August 9, 2017
    Manufacturer
    SYMMETRYSURGICAL, INC.
    Product Code
    EKE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) IN OPERATING ROOM, THE TIP OF A CURETTE BROKE OFF WHILE IN USE BY DOCTOR. THE SURGICAL SITE AND ROOM WERE SEARCHED. THE CURETTE WAS FOUND IN THE SUCTION FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568837 CURETTE, OPERATIVE EKE SYMMETRYSURGICAL, INC. 080-1420-3/0

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR