BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COTREL-DUBOUSSET INSTRUMENTATION WITH SACRO-ILIAC SCREWS

    MDR report key: 198493 · Received November 20, 1998

    Report

    Report Number
    MW1015032
    Event Type
    Injury
    Date Received
    November 20, 1998
    Date of Event
    August 7, 1990
    Report Date
    November 16, 1998
    Manufacturer
    DANEK MEDICAL, INC.
    Product Code
    MCV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ANTERIOR/POSTERIOR SPINAL FUSION EXTENSION LUMBAR-4 TO SACRUM WITH COTREL-DUBOUSSET SPINAL INSTRUMENTATION AND SACRO-ILIAC SCREWS WITH AUTOLOGOUS ILIAC BONE GRAFT. REDUCTION OF 25-30 DEGREES LORDOSIS AFTER IMPLANTATION OF COTREL-DUBOUSSET HARDWARE IMMEDIATELY PRODUCED FLATBACK DEFORMITY AND 3 CM CORONAL IMBALANCE, CAUSING CHRONIC KNEE, SACRO-ILIAC JOINT, AND OUTER HIP INFLAMMATION, IN ADDITION TO THORACIC OUTLET SYNDROME AND CERVICAL RADICULOPATHY OVER TIME. ROTATIONAL TORQUE OF COTREL-DUBOUSSET HARDWARE IS SUSPECTED TO HAVE TWISTED 18-YEAR-OLD THORACIC SPINAL FUSION, PRODUCING TWO OR MORE PSEUDOARTHROSES. PT HAD COTREL-DUBOUSSET HARDWARE REMOVAL MAY, 1997; LATERAL RETINACULAR RELEASE LEFT KNEE MARCH, 1998 TO REALIGN KNEECAP; 2 NERVE BLOCKS (JAN & OCT, 1998) ON HIPS; ON NARCOTIC PAIN RELIEVERS SINCE JAN 1, 1998. IN FEB, 1999 SPINAL FUSION REVISION SUEGERY IS SCHEDULED, WITH BIPLANAR OSTEOTOMY AT LUMBAR-3 WITH PEDICLE SCREWS AND ISOLA RODS TO CORRECT SAGGITAL AND CORONAL PLANE IMBALANCES. DURING THE OPERATION, THE SUSPECTED THORACIC PSEUDOARTHROSES WILL BE SURGICALLY EXPOSED AND REFUSED WITH BONE FROM A THORACOPLASTY, IF NECESSARY, WITH ONE UNIT OF SPINAL FIXATION HARDWARE EXTENDED INTO THE LUMBAR REGION. PT HAS BEEN SUBSTANTIALLY DISABLED SINCE MAY, 1996 WITH DIFFICULTIES IN WALKING, SITTING, AND STANDING IN ADDITION TO SEVERE, CHRONIC PAIN IN KNEES, HIPS, BACK, ARMS, HANDS, AND NECK/HEAD. SHE MAY FURTHER NEED SURGERY TO FUSE HER SACRO-ILIAC JOINTS DUE TO THE DEGENERATIVE DAMAGE CAUSED BY THE SACRO-ILIAC SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COTREL-DUBOUSSET INSTRUMENTATION WITH SACRO-ILIAC SCREWS Implant SPINAL FIXATION INSTRUMENTATION FOR SPINAL FUSION FOR SCOLIO MCV DANEK MEDICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R| S