BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER CERVICAL PLATE SYSTEM

    MDR report key: 1587600 · Received January 19, 2010

    Report

    Report Number
    3005031160-2010-00002
    Event Type
    Malfunction
    Date Received
    January 19, 2010
    Report Date
    January 12, 2010
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K052292
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE TYPE: SPINAL SURGERY - CERVICAL FUSION. ACCORDING TO THE REPORTER: THE DOCTOR NOTICED THAT THE PT HAD A SCREW BACKING OUT OF THE ANTERIOR CERVICAL PLATE. THE SURGEON WAS NOT PLANNING TO REVISE THE PT AT THIS TIME. THIS OCCURRED DURING ROUTINE POST OPERATIVE VISITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDER CERVICAL PLATE SYSTEM CERVICAL PLATE SPINAL SYSTEM KWQ X-SPINE SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1