BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR TOTAL ANKLE REPLACEMENT

    MDR report key: 3296016 · Received August 12, 2013

    Report

    Report Number
    3003640913-2013-00036
    Event Type
    Injury
    Date Received
    August 12, 2013
    Date of Event
    June 18, 2013
    Report Date
    August 9, 2013
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVISED COMPONENTS: STAR TOTAL ANKLE REPLACEMENT: MODEL#: 400-218; LOT#: 080498/543. DEVICE MFR DATE: UNK, EXP DATE: UNK; MODEL#: 400-232; LOT#: 050308/0890 DEVICE MFR DATE: UNK, EXP DATE: UNK. STAR ANKLE REVISED TO FUSION. VISUAL EVAL CONFIRMS THAT SLIDING CORE WAS FRACTURED.

    Description of Event or Problem · 1

    PT HAD STAR TOTAL ANKLE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385545 STAR TOTAL ANKLE REPLACEMENT SLIDING CORE NTG SMALL BONE INNOVATIONS, INC. 400-143 0725002

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention