BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION TREATMENT GUIDANCE PLATFORM

    MDR report key: 267641 · Received March 3, 2000

    Report

    Report Number
    1723170-2000-00002
    Event Type
    Injury
    Date Received
    March 3, 2000
    Date of Event
    January 1, 2000
    Report Date
    February 29, 2000
    Manufacturer
    MEDTRONIC SURGICAL NAV. TECH
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DOCTOR USED THE STEALTHSTATION AS AN ADJUNCT TO SURGERY AT A HOSP IN A FOREIGN COUNTRY FOR AN ORTHOPEDICA BONE SCREW PLACEMENT PROCEDURE. THE REPORTER, UPON INFO AND BELIEF, CLAIMS THAT THE IMAGE RECONSTRUCTION DISPLAYED BY THE STEALTHSTATION DID NOT MATCH THE PT'S ANATOMY. AS A RESULT, THE SCREWS WERE NOT SECURELY IMPLANTED. AFTER SURGERY, PT COMPLAINED OF PAIN IN THE BACK AND LEGS. A SECOND OPERATION WAS PERFORMED TO PLACE THE SCREWS IN A DIFFERENT POSITION. IT APPEARS THE SURGERY ALLEVIATED THE PT'S PAIN. THERE HAVE BEEN NO MORE COMPLAINTS FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREATMENT GUIDANCE PLATFORM IMAGE GUIDED STEREOTACTIC DEVICE HAW MEDTRONIC SURGICAL NAV. TECH STEALTHSTATION SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention