BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS ACP 3 LEVEL PLATE

    MDR report key: 3891440 · Received May 30, 2014

    Report

    Report Number
    3008853203-2014-00001
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    November 1, 2013
    Report Date
    May 27, 2014
    Manufacturer
    NEUROSTRUCTURES INC.
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON PHYSICAL EVALUATION OF THE ACTUAL DEVICE, DEEP WEAR/DAMAGE MARKS WERE OBSERVED THAT WERE INCONSISTENT WITH THE USER OF THE PLATE BENDER PROVIDED WITH THE SET. THE PLATE ALSO APPEARED TO BE BENT IN THE AREA OF THE DAMAGE MARKS, WHICH CAUSED A HEAVY LORDOSIS. THE REVIEW OF THE SUBJECT PLATE INDICATED THAT THE LOCKING MECHANISMS (CAM AND TABS) ARE STILL FUNCTIONAL. THE LOCKING CAM CAN ARTICULATE AND THE LOCKING TABS CAN BE EXPANDED. THE DRIVING FEATURE OF THE LOCKING CAM IS DEFORMED (ROUNDED) INDICATING THE SIGNIFICANT FORCE WAS APPLIED IN AN ATTEMPT TO ROTATE THE LOCKING CAM. THIS SITUATION CAN BE EXPLAINED BY AN ATTEMPT TO DEPLOY THE TABS (BLOCKING THE SCREW) WHILE THE SCREW WAS NOT FULLY SEATED. IF AN OBJECT IS IN THE WAY OF THE TABS AND EXCESSIVE FORCE IS APPLIED IN ORDER TO ROTATE THE CAM THE END RESULT WILL BE SIMILAR TO THE ONE PRESENTED WITH THE PLATE PROVIDED (DEFORMED DRIVING FEATURE).

    Description of Event or Problem · 1

    DR. VAN HAD ISSUES WITH THE BONE SCREW AT THE CAUDAL END OF THE CONSTRUCT. WHEN ATTEMPTING TO COVER THE BONE SCREWS THE LOCKING MECHANISM WOULD NOT DEPLOY. SO MUCH PRESSURE WAS EXERTED ON THE LOCKING MECHANISM IT DEFORMED THE LOCKING MECHANISM HOUSING (FOOTBALL). ALSO EXPERIENCED SOME DIFFICULTY ENGAGING HE REMOVAL TOOL. NOTE, THE PLATE APPEARS TO BE HEAVILY LORDOSED (BENDING) UPON EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319915 TEMPUS ACP 3 LEVEL PLATE ANTERIOR CERVICAL PLATE KWQ NEUROSTRUCTURES INC. 10-03-054 130074

    Patients

    Seq Age Sex Outcome Treatment
    1