BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRITON ATTACHMENT SAGITTAL SAW

    MDR report key: 384534 · Received March 20, 2002

    Report

    Report Number
    1625507-2002-00031
    Event Type
    Malfunction
    Date Received
    March 20, 2002
    Report Date
    February 17, 2002
    Manufacturer
    MEDTRONIC MIDAS REX
    Product Code
    HBE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CHEVRON OSTEOTOMY, THE MICRO SAGITTAL SAW WAS "BOGGING DOWN AND STALLING" CAUSING BURNING OF THE BONE AND SUBSEQUENT SLOWER THAN USUAL HEALING. NO ADD'L PT F/U INFO WAS OBTAINABLE FROM THE DOCTOR OF THE HOSPITAL PERSONNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRITON ATTACHMENT SAGITTAL SAW PNEUMATIC SURGICAL DRILL ATTACHMENT HBE MEDTRONIC MIDAS REX NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other