BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIA TREATMENT GUIDANCE SYSTEM

    MDR report key: 1569886 · Received December 31, 2009

    Report

    Report Number
    1723170-2009-00015
    Event Type
    Other
    Date Received
    December 31, 2009
    Date of Event
    December 3, 2009
    Report Date
    December 3, 2009
    Manufacturer
    MEDTRONIC NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K001153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT AVAILABLE, BUT HAS BEEN REQUESTED. REPORTED AS POSSIBLE INJURY COMPLICATION DUE TO MALPOSITIONING ON A (B)(6) PEDICLE SCREWS. TRIA SYSTEM WAS SERVICED AT THE HOSPITAL SITE AND THE CAMERA (PSU), TOOL INTERFACE UNIT (TIU), AND COMPUTER WERE REPLACED. MEDTRONIC NAVIGATION IS IN PROCESS OF HAVING THESE ITEMS RETURNED FOR FURTHER EVALUATION. A MORE DEFINITE CONCLUSION AWAITS COMPLETION OF THIS ADDITIONAL EVALUATION.

    Description of Event or Problem · 1

    REPORTED VIA MEDTRONIC SOFAMORE (B)(6): PATIENT UNDERWENT SPINAL FUSION WITH BILATERAL PEDICLE SCREW FIXATION AT TH3/4/5 AND TH9/10/11. PEDICLE SCREW INSERTION WAS ASSISTED BY NAVIGATION USING A TRIA SYSTEM. POST-OP CT SCAN FOUND MULTIPLE SCREWS MALPOSITIONED AT TH3/4/5. THE THREE SCREWS AT LEFT WERE FOUND INSERTED TOWARD SPINAL CANAL WHILE THE OTHER THREE AT RIGHT WERE FOUND DEVIATED LATERALLY FROM THE APPROPRIATE POSITIONS. THE PATIENT HAS BEEN ASYMPTOMATIC SO FAR AND THERE IS NO PLAN ON REVISION SURGERY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIA TREATMENT GUIDANCE SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION TRIA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other