BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECICE INTRAMEDULLARY LIMB LENGTHENING ROD

    MDR report key: 2831608 · Received November 7, 2012

    Report

    Report Number
    3006179046-2012-00017
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 15, 2012
    Report Date
    November 7, 2012
    Manufacturer
    ELLIPSE TECHNOLOGIES, INC.
    Product Code
    HSB
    PMA / PMN Number
    K101997
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED ON (B)(6) 2012. PT WAS PRESENTED 3 WEEKS POST-OP WITH A FEVER AND LOCAL TENDERNESS. THE WOUND WAS DEBRIDED 2 TIMES IN ORDER TO SALVAGE THE DEVICE. PT WAS ABLE TO KEEP THE DEVICE IN FOR THE ENTIRE LENGTHENING PROCESS. REVIEW OF STERILIZATION CERTIFICATION AND DEVICE HISTORY RECORDS CONFIRMS THE DEVICE WAS RELEASED IN SPECIFICATION. ELLIPSE IS UNABLE TO DETERMINE THE CAUSE OF THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECICE INTRAMEDULLARY LIMB LENGTHENING ROD INTRAMEDULLARY ROD HSB ELLIPSE TECHNOLOGIES, INC. LAA1-065 A120521-08

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR