BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD

    MDR report key: 3920238 · Received July 8, 2014

    Report

    Report Number
    3006179046-2014-00021
    Event Type
    Injury
    Date Received
    July 8, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ELLIPSE TECHNOLOGIES, INCORPORATED
    Product Code
    HSB
    PMA / PMN Number
    K113219
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S PRECICE NAIL WAS REMOVED AND A REOSTEOTOMY WAS PERFORMED ON THE PATIENT'S FEMUR. THE PATIENT WAS IMPLANTED WITH A NEW PRECICE NAIL, WITHOUT INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE DEVICE INVOLVED IN THE ALLEGED INCIDENT HAS NOT BEEN RETURNED; THEREFORE, NO EVALUATION CAN BE CONDUCTED. A DHR REVIEW REVEALED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS AND THE DEVICE WAS RELEASED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S PRECICE NAIL APPEARED TO HAVE HAD STOPPED LENGTHENING, APPROXIMATELY SIX (6) WEEKS AFTER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398117 PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ELLIPSE TECHNOLOGIES, INCORPORATED LAA2-065 A130221-01-R1

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other| R