BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS ANTERIOR CERVICAL PLATE

    MDR report key: 6674294 · Received June 28, 2017

    Report

    Report Number
    3008853203-2017-00005
    Event Type
    Malfunction
    Date Received
    June 28, 2017
    Date of Event
    June 14, 2017
    Report Date
    June 27, 2017
    Manufacturer
    NEUROSTRUCTURES,INC
    Product Code
    KWQ
    UDI-DI
    00841508100003
    PMA / PMN Number
    K131374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED A ACDF ON 5/3/17. NO KNOWN ISSUES AT THE TIME. THE SURGERY WAS SUCCESSFUL. PATIENT RETURNED WITH A SCREW PROTRUDING FROM THE TEMPUS CERVICAL PLATE. THE LOCKING RING BROKE FOR THE AFFECTED SCREW AND NEEDED A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456217 TEMPUS ANTERIOR CERVICAL PLATE TEMPUS, PRODUCT CODE: KWQ KWQ NEUROSTRUCTURES,INC 00841508100003

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR