BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SBI RADIO-CAPITELLAR IMPLANT

    MDR report key: 4079932 · Received August 25, 2014

    Report

    Report Number
    4079932
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 31, 2014
    Manufacturer
    SMALL BONE INNOVATIONS INC.
    Product Code
    JDB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    SALES REP DELIVERED THE COMPONENTS FOR SURGERY. WHEN THE TRAY WAS OPENED, THE O.R. REALIZED THAT ALL THE COMPONENTS OF THE IMPLANT TRAY WERE NOT AVAILABLE FOR SURGERY. PATIENT WAS BROUGHT INTO O.R. AND THE MISSING COMPONENT WAS NOT DISCOVERED UNTIL AFTER THE PATIENT WAS ALREADY GIVEN A NERVE BLOCK. PATIENT'S SURGERY HAD TO BE RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510743 SBI RADIO-CAPITELLAR IMPLANT PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED JDB SMALL BONE INNOVATIONS INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR