BEUDAMED
    FDA Adverse Event Other Summary report: N

    CDO SYSTEM

    MDR report key: 487207 · Received September 26, 2003

    Report

    Report Number
    2029012-2003-00031
    Event Type
    Other
    Date Received
    September 26, 2003
    Date of Event
    July 25, 2003
    Report Date
    September 25, 2003
    Manufacturer
    INTERPORE CROSS INTERNATIONAL
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WITH A PREOPERATIVE PAINFUL COMPRESSION FRACTURE AT L4. SURGERY WAS PERFORMED 2003 AT WHICH TIME 3.5CC OF J&J ENDURANCE CEMENT WAS DELIVERED TO THE SITE VIA THE CDO SYSTEM AND MODULAR TAMP. WHEN THE SURGEON FELT THE CEMENT HAD HARDENED SUFFICIENTLY, HE REMOVED THE CANNULA. AP AND LATERAL FILMS WERE TAKEN INTRAOPERATIVELY. AT THAT TIME, THERE DID NOT APPEAR TO BE A "CEMENT TAIL". THE PT WAS TAKEN TO RECOVERY AND WAS ABLE TO MOVE THEIR TOES WHEN THEY WERE AWAKENED BY HOSP PERSONNEL. ONE DAY POSTOPERATIVE THE PT EXPERIENCED NUMBNESS IN THE RIGHT LEG. AN X-RAY WAS TAKEN WHICH SHOWED A PROTRUDING CEMENT TAIL. THE PT WAS TAKEN BACK TO SURGERY THE SAME DAY AT WHICH TIME A LAMINECTONY WAS PERFORMED AND THE CEMENT TAIL WAS REMOVED. THE PT CONTINUES TO IMPROVE AND IS EXPECTED TO MAKE A COMPLETE RECOVERY. THEY ARE CURRENTLY UNDERGOING PHYSICAL THERAPY FOR 2 MONTHS AND WALKS WITH A CANE. THE SURGEON DID NOT EXPERIENCE ANY DIFFICULTY WITH THE CDO SYSTEM OR MODULAR TAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CDO SYSTEM MANUAL SURGICAL INSTRUMENT LXH INTERPORE CROSS INTERNATIONAL NA 306402

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention J&J ENDURANCE CEMENT