BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RE-MOTION

    MDR report key: 1909176 · Received November 8, 2010

    Report

    Report Number
    1909176
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 8, 2010
    Manufacturer
    SMALL BONE INNOVATIONS
    Product Code
    KXE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE WAS GOING ALONG FINE UNTIL THEY TRIED TO SNAP ON THE POLYPROLENE TO THE METAL IMPLANT. THEY TOOK IT APART AND NOTED THAT IT WAS NOT THE RIGHT SIZE. THE MANUFACTURER REPRESENTATIVE WAS IN THE OR SUITE AT THE TIME AND IMMEDIATELY NOTIFIED HIS SUPERVISOR THAT THE PRODUCT WAS DEFECTIVE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE PRODUCT WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RE-MOTION HAND IMPLANT KXE SMALL BONE INNOVATIONS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR NO OTHER THERAPIES