BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAXX XD

    MDR report key: 1760391 · Received July 9, 2010

    Report

    Report Number
    3004638600-2010-00003
    Event Type
    Injury
    Date Received
    July 9, 2010
    Date of Event
    June 8, 2010
    Report Date
    June 9, 2010
    Manufacturer
    SPINE WAVE, INC.
    Product Code
    MQP
    PMA / PMN Number
    K052670
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS NOT AVAILABLE FOR EVAL. NO CONCLUSION CAN BE MADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT SURGERY TO REMOVE THE IMPLANT, DUE TO PSEUDARTHROSIS APPROX FOURTEEN MONTHS POST-OPERATIVELY. THE SURGERY WAS REPORTED TO HAVE BEEN COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAXX XD SPINAL VERTEBRAL BODY REPLACEMENT MQP SPINE WAVE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention