BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS

    MDR report key: 7359004 · Received March 21, 2018

    Report

    Report Number
    3008853203-2018-00015
    Event Type
    Malfunction
    Date Received
    March 21, 2018
    Date of Event
    March 13, 2018
    Report Date
    March 21, 2018
    Manufacturer
    NEUROSTRUCTURES, INC.
    Product Code
    KWQ
    UDI-DI
    00841508100096
    PMA / PMN Number
    K131374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LOCKING MECHANISM WAS BROKEN. SCREW WAS PROTRUDING OUT OF THE PLATE AND BONE. PATIENT CAME IN FOR UNRELATED PAIN AND EVENT WAS DISCOVERED THROUGH AN X-RAY. X-RAY IS NOT AVAILABLE. REVISION SURGERY WAS DONE TODAY AND ALL BROKEN FRAGMENTS WERE RETRIEVED. NO SURGICAL DELAY. NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203450 TEMPUS CERVICAL PLATING SYSTEM KWQ NEUROSTRUCTURES, INC. 10-02-026 00841508100096

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR