BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES, USA

    MDR report key: 218612 · Received April 7, 1999

    Report

    Report Number
    218612
    Event Type
    Injury
    Date Received
    April 7, 1999
    Date of Event
    March 13, 1999
    Report Date
    March 22, 1999
    Manufacturer
    SYNTHES, USA
    Product Code
    MON
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SYNTHES INTRAORAL DISTRACTION APPLIANCE, WHICH WAS PLACED 3/3/1999 AND REPAIRED 3/8/1999 WAS REMOVED ON 3/13/1999 AND REPLACED WITH AN EXTRORAL DISTRACTION DEVICE. THE ORIGINAL DEVICE WAS APPARENTLY DEFECTIVE AND BECAME DISPLACED TWICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES, USA Implant DISTRACTION APPLIANCE MON SYNTHES, USA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization