BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPENSER, CEMENT

    MDR report key: 6773903 · Received August 8, 2017

    Report

    Report Number
    2520274-2017-12059
    Event Type
    Injury
    Date Received
    August 8, 2017
    Report Date
    July 26, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    KIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT FOR DIAGNOSIS. CABRERA E; ET AL (2011) GEER ABSTRACT- ARTICLE #20 ¿ PRELIMINARY CLINICAL RADIOLOGIC RESULTS OF KYPHOPLASTY AND VERTEBRAL STENTING IN THE TREATMENT OF OSTEOPOROTIC VERTEBRAL FRACTURES. EUR SPINE J, 20: 2067-2095. THIS REPORT IS FOR AN UNKNOWN VERTEBRAL BODY STENTING (UNKNOWN QUANTITY/UNKNOWN LOT). (OTHER NUMBER) UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. (B)(4). 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 SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: CABRERA E; ET AL (2011) GEER ABSTRACT- ARTICLE #20 ¿ PRELIMINARY CLINICAL RADIOLOGIC RESULTS OF KYPHOPLASTY AND VERTEBRAL STENTING IN THE TREATMENT OF OSTEOPOROTIC VERTEBRAL FRACTURES. EUR SPINE J, 20: 2067-2095. THIS IS A RETROSPECTIVE STUDY OF 31 PATIENTS WITH A LUMBAR OR LOWER THORACIC (D9¿12) VERTEBRAL FRACTURE AT A SINGLE LEVEL WITH POSTERIOR WALL INTEGRITY, TREATED BY KYPHOPLASTY WITH VERTEBRAL BODY STENTING (VBS, SYNTHES). MEAN AGE WAS 77.6 YEARS (69¿87 YEARS). MEAN FOLLOW-UP WAS 19 MONTHS (12¿ 27 MONTHS). THE MEAN POSTOPERATIVE HOSPITAL STAY WAS 24 H (24¿72 H). AT 1-YEAR FOLLOW-UP, THERE WAS NO LOSS OF THE HEIGHT ATTAINED. 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 RE-OPERATIONS WERE NEEDED. KYPHOPLASTY WITH VERTEBRAL STENTING IS A SAFE, USEFUL METHOD FOR TREATING OSTEOPOROTIC FRACTURES THAT ACHIEVES A SIGNIFICANT REDUCTION IN PAIN AND ANALGESIC REQUIREMENTS. OUR SERIES SHOWED ACCEPTABLE RESTORATION OF VERTEBRAL HEIGHT AND PARTIAL CORRECTION OF SAGITTAL ALIGNMENT. THIS IS 1 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN VERTEBRAL BODY STENTING AND REFERS TO THE SERIOUS INJURY/REPORTABLE MALFUNCTION OF 3 CASES OF CEMENT LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555718 DISPENSER, CEMENT KIH SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention