BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK EFFICIENCY SPHERE GENERAL SET

    MDR report key: 9847425 · Received March 18, 2020

    Report

    Report Number
    9847425
    Event Type
    Malfunction
    Date Received
    March 18, 2020
    Date of Event
    March 12, 2020
    Report Date
    March 16, 2020
    Manufacturer
    MEDACTA USA, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY PLASTIC IMPACTOR BROKE. X-RAYS: NOT RETAINED. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312906 GMK EFFICIENCY SPHERE GENERAL SET ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDACTA USA, INC. 1901015

    Patients

    Seq Age Sex Outcome Treatment
    1 21535 DA