BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDER CERVICAL PLATING SYSTEM SCREWS

    MDR report key: 2489697 · Received March 7, 2012

    Report

    Report Number
    3005031160-2012-00003
    Event Type
    Injury
    Date Received
    March 7, 2012
    Report Date
    February 6, 2012
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K052292
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: ANTERIOR CERVICAL DISCECTOMY AND 2-LEVEL FUSION (C5-C7). DATE OF INITIAL SURGERY: UNK. ACCORDING TO THE REPORTER: THE TOP SCREW OF THE CONSTRUCT BROKE POST-OPERATIVELY. THE SCREW WAS A 4.0MM VARIABLE SCREW. NO ADD'L INFO WAS OBTAINED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other