BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2524289 · Received April 9, 2012

    Report

    Report Number
    1030489-2012-00470
    Event Type
    Injury
    Date Received
    April 9, 2012
    Date of Event
    March 9, 2012
    Report Date
    March 15, 2012
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NQP
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: AUTHOR: F. DE IURE ET AL JOURNAL NAME: EUR SPINE J YEAR: 2012 ISSUE# DOI 10.1007/S00586-012-2219-X TITLE: POSTERIOR LUMBAR FUSION BY PEEK RODS IN DEGENERATIVE SPINE: PRELIMINARY REPORT ON 30 CASES. THE DEVICE OR APPLICABLE IMAGING STUDIES WERE NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTHORS RETROSPECTIVELY REVIEWED 30 CASES IN WHICH POSTERIOR FUSION WAS SUPPORTED BY PEEK RODS, ANALYZING EARLY COMPLICATIONS, RATE OF FUSION AND CLINICAL OUTCOME. AT AN AVERAGE FOLLOW-UP OF 18 MONTHS, BOTH CLINICAL AND RADIOGRAPHIC RESULTS WERE SATISFACTORY WITH ONLY ONE CASE REQUIRING SURGICAL REVISION FOR A MECHANICAL COMPLICATION. FROM (B)(6) 2008 TO (B)(6) 2010, 30 PATIENTS WITH DEGENERATIVE LUMBAR SPINE DISEASE WERE OPERATED. THERE WERE 13 MALES AND 17 FEMALES WITH AN AVERAGE AGE OF 61 YEARS (FROM (B)(6)). INTERBODY FUSION WITH PEEK CAGES WAS PERFORMED IN 22 CASES (1 DOUBLE LEVEL). EIGHT PATIENTS RECEIVED POSTEROLATERAL AUTOGENOUS GRAFTING ONLY. ONLY AUTOGENOUS BONE GRAFT BY ILIAC CREST AND POSTERIOR VERTEBRAL ARCH, HARVESTED FROM INSIDE THE OPERATORY FIELD, WAS USED. FUSION WAS ACHIEVED IN A REASONABLE TIME IN ALL PATIENTS WITH INTERBODY CAGES, AND THIS WAS THE MAIN TARGET OF THE NEW LOAD SHARING FEATURE AND IN 90% OF THE PATIENT WHO UNDERWENT POSTEROLATERAL FUSION. THERE WAS ONE INTRAOPERATIVE COMPLICATION OF A DURAL TEAR WHICH WAS IMMEDIATELY REPAIRED WITHOUT CLINICAL CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL NQP WARSAW ORTHOPEDICS NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention