BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2072687 · Received April 29, 2011

    Report

    Report Number
    1030489-2011-00467
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    October 6, 2010
    Report Date
    April 1, 2011
    Manufacturer
    MEDTONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: VOUGIOUKAS, V, ET AL. VERTEBROPLASTY COMBINED WITH IMAGE-GUIDED PERCUTANEOUS CEMENT AUGMENTED TRANSPEDICULAR FIXATION FOR THE TREATMENT OF COMPLEX VERTEBRAL FRACTURES IN OSTEOPOROTIC PATIENTS. J NEUROSURG SCIENCE 2011; 54:135-141. RODS - THERAPY DATES NOT PROVIDED PMMA BONE CEMENT - THERAPY DATES NOT PROVIDED. (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. ALTHOUGH IT IS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    POST-OPERATIVE COMPLICATIONS WERE REPORTED IN A RETROSPECTIVE REVIEW OF PATIENTS WITH SPONTANEOUS COMPRESSION FRACTURES (AO / TYPE A3) AND OSTEOPOROTIC CHANGES WITHOUT NEUROLOGICAL DEFICITS. FRACTURE LEVELS RANGED FROM T8 TO L3. THE PATIENTS WERE TREATED WITH SINGLE LEVEL VERTEBROPLASTY AND IMAGE GUIDED PERCUTANEOUS CEMENT AUGMENTED FIXATION OF THE AFFECTED SEGMENTS BETWEEN (B)(6) 2006 AND (B)(6) 2007. IN PATIENTS WITH RADICULAR PAIN, DECOMPRESSION OF THE AFFECTED NERVE ROOT WAS PERFORMED THROUGH A TUBULAR RETRACTOR SYSTEM DIRECTLY PRIOR TO INSTRUMENTATION. THERE WERE NO REPORTS OF SCREW BREAKAGE OR LOOSENING DURING FOLLOW UP PERIOD. THERE WERE NO CASES OF HARDWARE FAILURE REQUIRING SURGICAL REVISION. NONE OF THE PATIENTS EXPERIENCED ADDITIONAL POSTOPERATIVE NEUROLOGICAL DEFICITS RELATED TO SCREW BREAKAGE. THERE WERE NO WOUND INFECTIONS. POST-OPERATIVE X-RAYS CONFIRMED ADEQUATE SCREW PLACEMENT IN ALL CASES AND CLINICAL OUTCOME WAS SATISFACTORY IN ALL CASES. TOTAL HOSPITALIZATION TIME RANGED FROM 5 TO 15 DAYS. ONE PATIENT UNDERWENT PROLONGED HOSPITALIZATION DUE TO PULMONARY DECOMPENSATION. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM KWP MEDTONIC SOFAMOR DANEK NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| R