BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDER CERVICAL PLATING SYSTEM

    MDR report key: 1983890 · Received February 4, 2011

    Report

    Report Number
    3005031160-2011-00002
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    September 1, 2010
    Report Date
    January 7, 2011
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K052292
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    PROCEDURE TYPE: ANTERIOR CERVICAL DECOMPRESSION AND FUSION, C5-C7. ACCORDING TO THE REPORTER: ON (B)(6), 2009, THE PATIENT UNDERWENT ANTERIOR CERVICAL DECOMPRESSION AND FUSION, C5-C7 IN (B)(6), UTILIZING THE PRODUCTS FROM X-SPINE SYSTEMS, INC. UPON FOLLOW UP WITH THE SURGEON, RADIOGRAPHS OF THE CERVICAL SPINE REVEALED EVIDENCE OF FRACTURE OF THE C5 VERTEBRAL BODY SCREWS. BOTH SCREWS WERE FRACTURED, WITH LOSS OF ALIGNMENT AND SUBSIDENCE. THE PATIENT UNDERWENT ANOTHER CERVICAL SPINE SURGERY IN (B)(6) OF 2010. THE PREOPERATIVE DIAGNOSIS WAS PSEUDOARTHROSIS CERVICAL SPINE WITH FRACTURED HARDWARE, STATUS POST PREVIOUS FUSION ATTEMPT AT C4-5.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other