BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 3670272 · Received February 11, 2014

    Report

    Report Number
    3003640913-2014-00006
    Event Type
    Injury
    Date Received
    February 11, 2014
    Date of Event
    January 13, 2014
    Report Date
    January 14, 2014
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR FOR PART NO 400-144 LOT 0905035 NOTED THAT 1 OUT OF THE 50 PIECES WERE DISCARDED; ALL RELEASED PARTS WERE WITHIN SPECIFICATION. THE COMPANY'S SURGERY REPORT FORM INDICATES THE SLIDING CORE MOBILE BEARING WAS DISLOCATED.

    Description of Event or Problem · 1

    STAR TOTAL ANKLE REPLACEMENT SLIDING CORE MOBILE BEARING WAS EXCHANGED TO ADDRESS THE DISLOCATION OF COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88873 STAR TOTAL ANKLE REPLACEMENT SLIDING CORE MOBILE BEARING NTG SMALL BONE INNOVATIONS, INC. 400-144 0905035

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention