BEUDAMED
    FDA Adverse Event Other Summary report: N

    SR MCP IMPLANT

    MDR report key: 838784 · Received April 13, 2007

    Report

    Report Number
    3003640913-2007-00002
    Event Type
    Other
    Date Received
    April 13, 2007
    Date of Event
    January 5, 2007
    Report Date
    April 12, 2007
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    KYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER RECEIVED A REPORT ON EXPLANT OF A SR MCP DUE TO INFECTION. NO DEVICE FAILURE WAS REPORTED. USE OF THE DEVICE AT THE FACILITY WAS CONTINUED AFTER AN INVESTIGATION.

    Description of Event or Problem · 1

    AN SR MCP IMPLANT WAS REMOVED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SR MCP IMPLANT METACARPOPHALANGEAL IMPLANT KYJ SMALL BONE INNOVATIONS, INC. SR MCP *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other