BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS

    MDR report key: 7358999 · Received March 21, 2018

    Report

    Report Number
    3008853203-2018-00014
    Event Type
    Malfunction
    Date Received
    March 21, 2018
    Date of Event
    January 3, 2018
    Report Date
    March 21, 2018
    Manufacturer
    NEUROSTRUCTURES, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K131374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TEMPUS PLATES LOCKING MECHANISM WAS BROKEN REALIZED AT REVISION SURGERY. REVISION SURGERY: PATIENT HAD PAIN, SURGEON FELT IT WAS NOT FROM IMPLANT. THE PLATE WAS NOT EXPORTED, THE BOTTOM LEFT SCREW WAS REMOVED AND THE LOCKING MECHANISM WAS REMOVED AND RECOVERED AND WILL BE SENT BACK. THE PATIENT DID NOT FUSE. THERE WAS NO FALL. PATIENT HAS NORMAL BONE QUALITY AND NORMAL ACTIVITY LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203449 TEMPUS CERVICAL PLATE SYSTEM KWQ NEUROSTRUCTURES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1