BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAXX XD

    MDR report key: 3911580 · Received June 27, 2014

    Report

    Report Number
    3004638600-2014-00004
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 29, 2014
    Manufacturer
    SPINE WAVE, INC.
    Product Code
    MNH
    PMA / PMN Number
    K101288
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH BACK PAIN AND RADICULOPATHY AT APPROXIMATELY 14 MONTHS POST OPERATIVELY. A REOPERATION WAS PERFORMED TO REMOVE THE IMPLANTS AT WHICH TIME A TEAR TO THE DURA WAS NOTED IN THE LOCATION WHERE A PORTION OF THE IMPLANT WAS LOOSENED FROM THE CONSTRUCT AND STICKING OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376340 STAXX XD SPINAL VERTEBRAL BODY REPLACEMENT MNH SPINE WAVE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention