BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTER-PHALANGEAL STERILE SURGICAL KIT

    MDR report key: 3964868 · Received July 17, 2014

    Report

    Report Number
    2027754-2014-00008
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    July 16, 2014
    Manufacturer
    OSTEOMED
    Product Code
    KWH
    PMA / PMN Number
    K022887
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON INADVERTENTLY IMPLANTED THE TRIAL OF SURGICAL KIT 360-2200 INSTEAD OF THE ACTUAL IMPLANT (360-2240).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420459 INTER-PHALANGEAL STERILE SURGICAL KIT INTERPHLEX FLEXIBLE STABILITY RODS KWH OSTEOMED 360-2240T 1072754

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization