BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1014252 · Received March 12, 2008

    Report

    Report Number
    1720753-2008-17944
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 11, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    II GRID.

    Description of Event or Problem · 1

    CUSTOMER REPORT THAT THE DOCTOR HAD THE PATIENT ARM ON THE SURFACE OF THE I.I. GRID AND WAS INSERTING A SCREW WHEN THE DOCTOR SLIPPED AND DRILLED THE SCREW INTO THE I.I. GRID. THE SCREW WENT THROUGH THE I.I. GRID BUT DID NOT TOUCH THE SURFACE OF THE I.I. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1