BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNERGY SPINAL SYSTEM

    MDR report key: 515665 · Received March 12, 2004

    Report

    Report Number
    2029012-2004-00013
    Event Type
    Other
    Date Received
    March 12, 2004
    Date of Event
    February 11, 2004
    Report Date
    March 12, 2004
    Manufacturer
    INTERPORE CROSS INTERNATIONAL
    Product Code
    KWO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    GROWTH ROD FRACTURED 11 MONTHS POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY SPINAL SYSTEM ORTHOPEDIC IMPLANT KWO INTERPORE CROSS INTERNATIONAL NA 30476

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization| R