BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINE ASSIST

    MDR report key: 1210873 · Received October 22, 2008

    Report

    Report Number
    MW5008729
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 22, 2008
    Manufacturer
    MAZUR SURGICAL TECHNOLOGIES LTD.
    Product Code
    HAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE MAZUR SPINE ROBOT IS A TRAJECTORY FINDING DEVICE FOR THE PLACEMENT OF PEDICLE SCREWS IN THE SPINE. I HAVE USED THE DEVICE ABOUT FOUR TIMES WITH NO IDENTIFIABLE PROBLEMS, ALTHOUGH AT LEAST ONCE ITS USE WAS ABANDONED FOR TECHNICAL REASONS. IN A CASE IN WHICH LANDMARKS HAD BEEN OBLITERATED DUE TO PRIOR SURGERY, THREE TRAJECTORIES NEEDED TO BE FOUND. THE PATIENT'S PRE-OPERATIVE CT WAS REGISTERED TO INTRAOP FLUOROSCOPIC IMAGES AS IS THE NORMAL ROUTINE. THE THREE TRAJECTORIES WERE IDENTIFIED, DRILLED, TAPPED AND A SCREW WAS INSERTED. THE LATERAL X-RAY APPEARED NORMAL. THE AP X-RAY WAS INTERPRETED BY ME -INCORRECTLY- AS NORMAL. DIAGNOSIS OR REASON FOR USE: LUMBAR DEGENERATIVE DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINE ASSIST TRAJECTORY FINDING ROBOT HAW MAZUR SURGICAL TECHNOLOGIES LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| O