BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINEART ANGLED TRIAL R SIDE 17MM H10

    MDR report key: 11453016 · Received March 10, 2021

    Report

    Report Number
    11453016
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Date of Event
    February 23, 2021
    Report Date
    March 1, 2021
    Manufacturer
    SPINEART SA
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    LATERAL TRIAL INSTRUMENT BROKE DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353891 SPINEART ANGLED TRIAL R SIDE 17MM H10 INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX SPINEART SA

    Patients

    Seq Age Sex Outcome Treatment
    1 23360 DA