BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT, FIXATION DEVICE, SPINAL

    MDR report key: 3761826 · Received April 21, 2014

    Report

    Report Number
    2520274-2014-10925
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Report Date
    April 10, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    JDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CABRERA, E., ALEJANDRO, L., (2011), PRELIMINARY CLINICAL-RADIOLOGIC RESULTS OF KYPHOPLASTY AND VERTEBRAL STENTING IN THE TREATMENT OF OSTEOPOROTIC VERTEBRAL FRACTURE, EUROPEAN SPINE JOURNAL, 20:2067¿2095. DOI 10.1007/S00586-011-2013-1. THIS REPORT IS FOR AN UNKNOWN VERTEBRAL BODY STENTING CEMENT. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: CABRERA, E., ALEJANDRO, L., (2011), PRELIMINARY CLINICAL-RADIOLOGIC RESULTS OF KYPHOPLASTY AND VERTEBRAL STENTING IN THE TREATMENT OF OSTEOPOROTIC VERTEBRAL FRACTURE, EUROPEAN SPINE JOURNAL, 20:2067-2095. DOI 10.1007/S00586-011-2013-1. THE INCIDENCE OF VERTEBRAL OSTEOPOROTIC FRACTURES IS INCREASING. IT IS NOW THE MOST COMMON OSTEOPOROTIC FRACTURE AND AN IMPORTANT PUBLIC HEALTH PROBLEM INVOLVING CONSIDERABLE HEALTHCARE COST. IN THIS STUDY, THE PRELIMINARY CLINICAL AND RADIOLOGIC RESULTS OF KYPHOPLASTY WITH VERTEBRAL STENTING ARE REPORTED A RETROSPECTIVE STUDY OF 31 PATIENTS WITH A LUMBAR OR LOWER THORACIC VERTEBRAL FRACTURE AT A SINGLE LEVEL WITH POSTERIOR WALL INTEGRITY, TREATED BY KYPHOPLASTY WITH VERTEBRAL BODY STENTING. MEAN AGE WAS RANGE WAS 69 THROUGH 87 YEARS. MEAN FOLLOW-UP WAS 12 TO 27 MONTHS. COMPLICATIONS THAT WAS REPORTED ARE THREE CASES OF ASYMPTOMATIC CEMENT LEAK OCCURRED AND TWO CASES OF VERTEBRAL FRACTURE IN SEGMENTS ADJACENT TO THE TREATED VERTEBRA. THERE WERE NO INFECTIONS OR COMPLICATIONS. NO REOPERATIONS WERE NEEDED. THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS. CEMENT LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241252 IMPLANT, FIXATION DEVICE, SPINAL JDN SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention