BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZION SPINAL SYSTEM

    MDR report key: 4419109 · Received January 14, 2015

    Report

    Report Number
    1030489-2015-00143
    Event Type
    Injury
    Date Received
    January 14, 2015
    Report Date
    December 16, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: CHONG SUH LEE, MD, PHD, ET AL. A COMPARATIVE STUDY BETWEEN THORACOSCOPIC SURGERY AND POSTERIOR SURGERY USING AL L-PEDICLE-SCREW CONSTRUCTS IN THE TREATMENT OF ADOLESCENT IDIOPATHIC SCOLIOSIS. J SPINAL DISORD TECH 2013;26:325¿333 (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE TITLED ¿A COMPARATIVE STUDY BETWEEN THORACOSCOPIC SURGERY AND POSTERIOR SURGERY USING ALL-PEDICLE-SCREW CONSTRUCTS IN THE TREATMENT OF ADOLESCENT IDIOPATHIC SCOLIOSIS¿ THAT SIXTY-FIVE PATIENTS WITH LENKE TYPE-1 AIS WERE INCLUDED AND FOLLOWED UP FOR A MINIMUM OF 24 MONTHS. FORTY-TWO PATIENTS UNDERWENT THORACOSCOPIC SURGERY (THORACOSCOPIC GROUP) AND 23 PATIENTS UNDERWENT POSTERIOR SURGERY (POSTERIOR GROUP). RADIOGRAPHIC OUTCOMES, INCLUDING THE CORRECTION RATE AND LOSS OF CORRECTION, PERIOPERATIVE MORBIDITIES, AND COMPLICATIONS, WERE COMPARED. THE THORACOSCOPIC GROUP INCLUDED 35 WOMEN AND 7 MEN. THEIR MEAN AGE WAS 15.9 YEARS, AND THE MEAN FOLLOW-UP DURATION WAS 58.5 MONTHS. THE POSTERIOR GROUP INCLUDED 20 WOMEN AND 3 MEN. THEIR MEAN AGE WAS 14.8 YEARS, AND THE MEAN FOLLOW-UP DURATION WAS 54.3 MONTHS. IN THE THORACOSCOPIC GROUP, THERE WERE 28 LENKE TYPE-1AN CURVES, 9 LENKE TYPE-1BN CURVES, AND 5 LENKE TYPE-1CN CURVES. IN THE POSTERIOR GROUP, THERE WERE 14 LENKE TYPE-1AN CURVES, 4 LENKE TYPE 1-BN CURVES, AND 5 LENKE-TYPE 1-CN CURVES. THE MEAN PREOPERATIVE MAGNITUDE OF THE MAJOR CURVE WAS 52.2 DEGREES IN THE THORACOSCOPIC GROUP AND 55.0 DEGREES IN THE POSTERIOR GROUP, YIELDING NO SIGNIFICANT DIFFERENCE (P=0.348). THE MEAN FLEXIBILITY OF THE MAJOR CURVE ON SIDE-BENDING RADIOGRAPH WAS 63.0% IN THE THORACOSCOPIC GROUP AND 54.9% IN THE POSTERIOR GROUP, SHOWING NO SIGNIFICANT DIFFERENCE (P=0.137). PATIENTS HAD THORACIC KYPHOSIS WITHIN THE RANGE OF 2.0¿47.0 DEGREES IN THE THORACOSCOPIC GROUP AND 1.3¿40 DEGREES IN THE POSTERIOR GROUP. IN ONE CASE ROD BREAKAGE WAS OBSERVED AT 1.5 YEARS POSTOPERATIVELY AND THE DEFORMITY HAD PROGRESSED THEREAFTER. REVISIONAL POSTERIOR FUSION SURGERY WAS RECOMMENDED, BUT THE PATIENT HAS NOT DECIDED TO UNDERGO SURGERY YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32072 CD HORIZION SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00015 YR Other