BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSI FRACTURE TABLE TOP

    MDR report key: 2618040 · Received June 6, 2012

    Report

    Report Number
    2618040
    Event Type
    Malfunction
    Date Received
    June 6, 2012
    Date of Event
    June 2, 2012
    Report Date
    June 6, 2012
    Manufacturer
    MIZUHO OSI
    Product Code
    JEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TRAUMA PATIENT WAS PLACED ON OSI FRACTURE TABLE FOR REPAIR OF RIGHT TROCANTERIC FEMUR FRACTURE WHEN THE OSI TABLE BROKE IN HALF AT SUPPORT ROD. PATIENT SLID TO SEATED POSITION WITHOUT FALLING OFF THE FRAME, AND WAS LOWERED TO THE FLOOR. A SECOND OSI TABLE WAS INSPECTED AND BROUGHT TO THE OR AND THE SURGERY WAS SUBSEQUENTLY COMPLETED WITH NO APPARENT HARM TO THE PATIENT. UPON INSPECTION, THE GLUE POINT FOR THE STEEL INSERT MAY HAVE FAILED.======================MANUFACTURER RESPONSE FOR FRACTURE TABLE, OSI FRACTURE TABLE TOP (PER SITE REPORTER).======================SALES REP COMING TOMORROW (B)6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSI FRACTURE TABLE TOP FRACTURE TABLE JEA MIZUHO OSI 5855 *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR