BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDER CERVICAL PLATE SYSTEM

    MDR report key: 1476980 · Received September 17, 2009

    Report

    Report Number
    3005031160-2009-00014
    Event Type
    Injury
    Date Received
    September 17, 2009
    Report Date
    August 20, 2009
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K052292
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT: 09/17/2009.

    Description of Event or Problem · 1

    PROCEDURE TYPE: SPINAL SURGERY - CERVICAL FUSION. ACCORDING TO THE RPTR: SCREWS BACKED OUT OF THE CERVICAL PLATE POST-OPERATIVELY. A REVISION SURGERY WAS THEN PERFORMED. NO FURTHER INFO IS CURRENTLY KNOWN.

    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 Required Intervention