BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTOPEDIC SYSTEMS, INC. (OSI)

    MDR report key: 269415 · Received March 10, 2000

    Report

    Report Number
    269415
    Event Type
    Injury
    Date Received
    March 10, 2000
    Date of Event
    March 1, 2000
    Report Date
    March 9, 2000
    Manufacturer
    ORTHOPEDIC SYSTEMS, INC.
    Product Code
    FWZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING A TRIPLE SPINAL FUSION SURGERY AND WAS PLACED ON THE DEVICE THAT IS RECOMMENDED BY THE MFR FOR USE WITH THE TABLE (ANDREWS SPINAL SURGERY TABLE). THE DEVICE IS A SEVEN INCH HEADREST PILLOW. THE FOLLOWING MORNING AFTER SURGERY THE PT HAD NO VISION IN THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTOPEDIC SYSTEMS, INC. (OSI) HEADREST PART OF KIT MODEL 5810 FWZ ORTHOPEDIC SYSTEMS, INC. MODEL 5810 *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| O TABLE.| THIS DEVICE WAS USED WITH ANDREWS SPINAL SURGERY