BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT, SURGICAL INSTRUMENT, DISPOSABLE

    MDR report key: 11699480 · Received April 21, 2021

    Report

    Report Number
    11699480
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    April 14, 2021
    Report Date
    April 20, 2021
    Manufacturer
    SPINEOLOGY, INC.
    Product Code
    KDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE STRAIGHT CURETTE BY SPINEOLOGY BROKE OFF INTO THE SPINE OF THE PATIENT. SURGEON RETRIEVED THE BROKEN PIECE UNDER X-RAY GUIDANCE. NO PIECES LEFT IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600089 KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD SPINEOLOGY, INC. 303-0069

    Patients

    Seq Age Sex Outcome Treatment
    1