BEUDAMED
    FDA Adverse Event Other Summary report: N

    JACKSON TABLE

    MDR report key: 492156 · Received October 23, 2003

    Report

    Report Number
    492156
    Event Type
    Other
    Date Received
    October 23, 2003
    Date of Event
    August 22, 2003
    Report Date
    September 8, 2003
    Manufacturer
    ORTHOPEDIC SYSTEMS, INC. (OSI)
    Product Code
    JEA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2003, PT WAS UNDER ANESTHESIA LAYING IN PRONE POSITION ON DEVICE #1. PHYSICIAN WAS USING HAND CONTROL TO ADJUST TABLE BUT WAS NOT RESPONDING. WHILE WAITING FOR ENGINEERING TO RESPOND, PHYSICIAN RELEASED THE LOCK ON THE TABLE AND THE PT'S WEIGHT MADE THE TABLE FLIP TO WHERE THE PT FELL TO THE FLOOR, SUSTAINING A SCALP INJURY. THE PT WAS AWAKENED IN THE OR AND ASSESSED BY THE PHYSICIANS. A CT SCAN WAS PERFORMED ON THE PT, WHICH REVEALED MINOR SOFT TISSUE INJURY TO RIB CARTILAGE. THE ORIGINAL SURGERY PROCEDURE WAS PERFORMED AT 1400 HOURS AND THE HEAD LACERATION WAS SUTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JACKSON TABLE SPINAL SURGERY TABLE JEA ORTHOPEDIC SYSTEMS, INC. (OSI) 5892 *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other