BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAXX XD

    MDR report key: 1241105 · Received November 21, 2008

    Report

    Report Number
    3004638600-2008-00002
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 22, 2008
    Manufacturer
    SPINE WAVE, INC.
    Product Code
    MQP
    PMA / PMN Number
    K052670
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED CONSTRUCT WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL INSPECTION REVEALED MARKINGS CONSISTENT WITH IMPLANTATION OF THE DEVICE. DIMENSIONAL INSPECTION SAMPLING OF THE CONSTRUCT DID NOT REVEAL ANY ABNORMALITIES. ALTHOUGH THE SURGEON HAS REPORTED THAT THE PATIENT ANATOMY AND PREVIOUS SURGERIES COMPLICATED THE INITIAL PROCEDURE, NO CONCLUSION CAN BE DRAWN FROM THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN THREE MONTHS POST-OPERATIVELY. THE PATIENT UNDERWENT REVISION SURGERY. DURING REVISION SURGERY, IT WAS REPORTED THAT THE CONSTRUCT WAS DISLODGED AND THE CONSTRUCT HAD MIGRATED. ACCORDING TO THE SURGEON, THIS WAS A DIFFICULT CASE DUE TO THE PATIENT'S ANATOMY AND PREVIOUS SURGICAL PROCEDURES. THE SURGEON REPORTED THAT THE REVISION SURGERY WAS 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 Required Intervention