BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    28MM TEMPUS CERVICAL PLATE SYSTEM

    MDR report key: 4788964 · Received May 15, 2015

    Report

    Report Number
    3008853203-2015-00026
    Event Type
    Malfunction
    Date Received
    May 15, 2015
    Date of Event
    April 28, 2015
    Report Date
    May 14, 2015
    Manufacturer
    NEUROSTRUCTURES INC.
    Product Code
    KWQ
    PMA / PMN Number
    K120515
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THAT THEY HAD TROUBLE LOCKING THE PLATE AND BELIEVE THAT THE SCREW BACKED OUT BY A FEW TURNS. DEVICE REMAINS IMPLANTED AS REVISION SURGERY IS NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317850 28MM TEMPUS CERVICAL PLATE SYSTEM ANTERIOR CERVICAL PLATE SYSTEM KWQ NEUROSTRUCTURES INC. 10-02-028

    Patients

    Seq Age Sex Outcome Treatment
    1