BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABO ACP SYSTEM

    MDR report key: 7308759 · Received March 1, 2018

    Report

    Report Number
    3008853203-2018-00013
    Event Type
    Malfunction
    Date Received
    March 1, 2018
    Report Date
    March 1, 2018
    Manufacturer
    NEUROSTRUCTURES, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K142060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EMAIL RECEIVED FROM A TERRITORY MANAGER: "THE ATTACHED IMAGE IS FROM ONE OF DR. (B)(6) PATIENTS. THE MRI SHOWS A BROKEN SCREW AT THE TOP VERTEBRAL LEVEL. THIS PATIENT IS FUSED AND DR. (B)(6) IS NOT RECOMMENDING REVISION AT THIS POINT. HE WILL NOT REVISE UNLESS THE PLATE BEGINS TO PUSH OFF OF THE VERTEBRAL BODY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148846 CABO ACP SYSTEM SCREW KWQ NEUROSTRUCTURES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1