BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNERGY SPINAL SYSTEM

    MDR report key: 618635 · Received June 30, 2005

    Report

    Report Number
    2029012-2005-00032
    Event Type
    Other
    Date Received
    June 30, 2005
    Date of Event
    June 2, 2005
    Report Date
    June 30, 2005
    Manufacturer
    INTERPORE CROSS INTL.
    Product Code
    JDK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DIFFICULTIES WERE EXPERIENCED DURING SURGERY, AS SCREWS WOULD NOT SEAT PROPERLY ONTO THE SEAT. EXCESS FORCE WAS APPLIED IN ORDER TO ASSEMBLE THE IMPLANTS TOGETHER. THERE WAS NO PT HARM OR INJURY AND THE CASE WAS COMPLETED UNVENTFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY SPINAL SYSTEM ORTHOPEDIC IMPLANT JDK INTERPORE CROSS INTL. NA SEE ATTACHMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other| R