BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNERGY SPINAL SYSTEM

    MDR report key: 512892 · Received February 25, 2004

    Report

    Report Number
    2029012-2004-00009
    Event Type
    Other
    Date Received
    February 25, 2004
    Date of Event
    January 14, 2004
    Report Date
    February 25, 2004
    Manufacturer
    INTERPORE CROSS INTL.
    Product Code
    KWO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT ORIGINALLY HAD SURGERY IN 2003. POST-OP X-RAYS INDICATED THAT THE ROD HAD SLIPPED. A SECOND SURGERY WAS REQUIRED IN 2004 TO REPLACE THE RODS AND LOOSE CAP NUTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY SPINAL SYSTEM ORTHOPEDIC IMPLANT KWO INTERPORE CROSS INTL. NA 31855

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R