BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAXX XD

    MDR report key: 1760392 · Received July 9, 2010

    Report

    Report Number
    3004638600-2010-00004
    Event Type
    Injury
    Date Received
    July 9, 2010
    Date of Event
    May 19, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE EXPLANTED DEVICE WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION WAS PERFORMED. MARKINGS OBSERVED ON THE DEVICE WERE CONSISTENT WITH THE REPORTED REMOVAL TECHNIQUE EMPLOYED BY THE SURGEON. OTHERWISE, NO VISUAL ABNORMALITIES WERE OBSERVED. NO CONCLUSION CAN BE DRAWN FROM THE RESULTS OF THE EXAMINATION OF THE RETURNED DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO REMOVE THE CONSTRUCT THAT HAD MIGRATED. 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 274G46

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention