BEUDAMED
    FDA Adverse Event Injury Summary report: N

    START TOTAL ANKLE REPLACEMENT`

    MDR report key: 4218710 · Received October 30, 2014

    Report

    Report Number
    3003640913-2014-00083
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REMOVED COMPONENTS: SLIDING CORE MOBILE BEARING; MODEL#: 400-142; LOT#: 0945163; EXPIRATION DATE: 01/01/2015; DEVICE MANUFACTURE DATE: 01/2010. VISUAL EXAMINATION OF EXPLANTS SHOW INSIGNIFICANT WEAR AND EVIDENCE OF GOOD OSSEOINTEGRATION. THERE WERE NO DEVIATIONS REPORTED IN THE DHRS EITHER PART NO. (B)(4), LOT NO. 0913039, AND PART NO. (B)(4), LOT NO. 090303/0252. ALL RELEASED PARTS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    START TOTAL ANKLE REPLACEMENT TALAR COMPONENT WAS EXCHANGED TO CORRECT SIZING ISSUE. THE SLIDING CORE MOBILE BEARING WAS ALSO EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696531 START TOTAL ANKLE REPLACEMENT` NTG SMALL BONE INNOVATIONS, INC. 400-254 091015/0713

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention