BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 219474 · Received April 20, 1999

    Report

    Report Number
    2520274-1999-00022
    Event Type
    Injury
    Date Received
    April 20, 1999
    Date of Event
    March 20, 1999
    Report Date
    March 23, 1999
    Manufacturer
    SYNTHES (USA)
    Product Code
    HNQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SUBJECT DEVICES WERE IMPLANTED ON 3/1/99. ON 3/20/99, WHILE THE PT WAS BENDING TO VOMIT, THE SUBJECT DEVICES CAME LOOSE FROM THE CONCOMITANT DEVICES. ON 3/22/99, ANOTHER SURGERY WAS PERFORMED TO REMOVE THE SUBJECT DEVICES AND REPLACE WITH NEW DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI Implant HOOKS HNQ SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention ROD, SCREWS, NUTS (03/01/1999 TO 03/22/1999).