BEUDAMED
    FDA Adverse Event Other Summary report: N

    MOBILE C-ARM X-RAY SYSTEM

    MDR report key: 28899 · Received November 10, 1995

    Report

    Report Number
    28899
    Event Type
    Other
    Date Received
    November 10, 1995
    Report Date
    November 9, 1995
    Manufacturer
    OEC MEDICAL SYSTEMS, INC.
    Product Code
    IZL
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INADEQUATE IMAGE WHEN PLACING ILLIOSACRAL SCREW INTO BODY OF S1 VERTEBRAE. UNABLE TO VISUALIZE SACRAL FORAMEN WHEN PLACING SCREW. WHEN RE-CHECKING PLACEMENT WITH FLUOROSCOPY UNIT SCREW HAD BROACHED THE FIRST SACRAL FORAMEN. SCREW WAS RE-POSITIONED INTRAOPERATIVELY. REQUIRED PROLONGED SURGICAL TIME TO WAIT FOR SECOND FLUOROSCOPY UNIT AND TO RE-POSITION SCREW. OEC UNIT UNABLE TO VISUALIZE PROXIMAL FEMORAL NECK AND HEAD. POST-OP CT SCAN INDICATES THAT HARDWARE BROACHED THE ANTERIOR NECK. WILL REQUIRE A RETURN TO OR FOR SECOND OPERATION TO REMOVE HARDWARE AND ADD'L CT SCAN AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOBILE C-ARM X-RAY SYSTEM MOBILE C-ARM X-RAY SYSTEM IZL OEC MEDICAL SYSTEMS, INC. 9600

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other