BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNI-ELBOW RADIO-CAPITELLUM SYSTEM

    MDR report key: 4177117 · Received October 14, 2014

    Report

    Report Number
    3003640913-2014-00076
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE ORDERING PROCESS CONFIRMS THAT ONLY ONE OF THE TWO NECESSARY IMPLANT BANKS FOR THE UNI-ELBOW RADIO-CAPITELLUM SYSTEM WAS ORDERED. THE COMPANY SALES REP CONFIRMS THAT REQUIRED IMPLANT BANK TO COMPLETE THE SURGERY WAS MISSING.

    Description of Event or Problem · 1

    THE COMPANY SALES REP BROUGHT AN INCOMPLETE IMPLANT SYSTEM TO THE FACILITY FOR A SURGICAL CASE. THE IMPLANT SYSTEM CONSISTS OF TWO IMPLANT BANKS, BUT ONLY ONE OF THE TWO IMPLANT BANKS WERE ORDERED AND SHIPPED TO THE FACILITY. THE PT WAS IN THE OPERATING ROOM AND A NERVE BLOCKER HAD ALREADY BEEN ADMINISTERED WHEN IT WAS DISCOVERED THAT ONLY ONE OF THE TWO IMPLANT BANKS WERE AVAILABLE. SURGERY WAS RESCHEDULED AAS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650352 UNI-ELBOW RADIO-CAPITELLUM SYSTEM IMPLANT BANK NTG SMALL BONE INNOVATIONS, INC. 100-0033 0004

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other