BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS CERVICAL PLATE SYSTEM

    MDR report key: 3891439 · Received May 30, 2014

    Report

    Report Number
    3008853203-2014-00002
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    November 11, 2013
    Report Date
    May 27, 2014
    Manufacturer
    NEUROSTRUCTURES INC.
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE CANNOT CONCLUDE THAT USING INSTRUMENTS THAT ARE NOT PART OF THE SET RESULTED IN THE FAILURE OF THE REVISION DRIVER. NO DAMAGE WAS FOUND IN ANY OF THE IMPLANTS THAT CAN EXPLAIN THE FAILURE FO THE REVISION DRIVER. THIS SITUATION CAN BE EXPLAINED BY APPLYING MORE TORQUE THAN NEEDED TO ALLOW SCREW REMOVAL. APPLYING EXCESSIVE TORQUING FORCE TO THE KNOB CAN RESULT IN FAILURE AS NOTICED IN THIS CASE.

    Description of Event or Problem · 1

    REVISION DRIVER BROKE DURING SURGERY. PATIENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320137 TEMPUS CERVICAL PLATE SYSTEM REVISION DRIVER KWQ NEUROSTRUCTURES INC. 10-90-019 130097

    Patients

    Seq Age Sex Outcome Treatment
    1