BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRAOSSEOUS FIXATION SYSTEM

    MDR report key: 3201550 · Received June 28, 2013

    Report

    Report Number
    3005039508-2013-00011
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    HTY
    PMA / PMN Number
    K120165
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT IS REPORTED THAT A PATIENT UNDERWENT FOOT SURGERY, USING AN IFS IMPLANT FOR HAMMERTOE, AND TWO WEEKS POST-OPERATION, THE IMPLANT WAS DISLOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296370 INTRAOSSEOUS FIXATION SYSTEM PIN, FIXATION, SMOOTH HTY ORTHOHELIX SURGICAL DESIGNS, INC. IFS-010-29-08

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention