BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEBRAL AUGMENTATION ACCESS KIT

    MDR report key: 3110714 · Received May 14, 2013

    Report

    Report Number
    2520274-2013-02533
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 16, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    LOD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODES: FZX, HXG, HTW, MJG. 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.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS REVIEW OF RADIOGRAPHIC IMAGES NOTED ONE IMAGE SHOWED NO VISIBLE CEMENT EXTRAVASATION; ONE IMAGE SHOWED POSTERIOR CEMENT EXTRAVASATION AT L3; ONE SHOWED CEMENT EXTRAVASATION INTO AN UNKNOWN INTERVERTEBRAL SPACE; AND ONE SHOWED ANTERIOR CEMENT EXTRAVASATION AT AN UNKNOWN VERTEBRAL LEVEL.

    Description of Event or Problem · 1

    LITERATURE ARTICLE TITLED: VERTEBRAL BODY STENTING VERSUS KYPHOPLASTY FOR THE TREATMENT OF OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES: A RANDOMIZED TRIAL WAS RECEIVED. AUTHORS: THIS STUDY INCLUDED 65 UNIDENTIFIED PATIENTS WITH A MEAN AGE OF (B)(6) (40 WOMEN AND 25 MEN) ENROLLED DIAGNOSED WITH OSTEOPOROTIC COMPRESSION FRACTURES. A TOTAL OF 100 VERTEBRAL LEVELS WERE TREATED IN THIS STUDY. OF THE 100 LEVELS, 50 OF THE UNSPECIFIED LEVELS UNDERWENT SYNTHES VERTEBRAL BODY STENTING BALLOON SYSTEM (VBS). THE REMAINING UNSPECIFIED 50 LEVELS WERE RELATED TO COMPETITORS BALLOON KYPHOPLASTY. OF THE 50 LEVELS TREATED WITH (VBS), 10 LEVELS EXPERIENCED MINOR CEMENT LEAKAGE, 5 LEVELS EXPERIENCED MAJOR CEMENT LEAKAGE. IT IS IMPORTANT TO NOTE THAT THE ARTICLE REPORTED THAT THE CEMENT LEAKAGE WAS PRIMARILY A RADIOGRAPHIC FINDING THAT IS NOT ALWAYS FOLLOWED BY CLINICAL SYMPTOMS. MATERIAL RELATED COMPLICATIONS INCLUDED (5) CANNULA RELATED COMPLICATIONS, 1 BALLOON RELATED COMPLICATION AND 3 STENT RELATED COMPLICATIONS. SEVERAL MATERIAL RELATED COMPLICATIONS OCCURRED OUTSIDE THE PATIENT (SUPPLIER UNSPECIFIED). THESE WERE MAINLY BREAKAGE OF THE TROCARS PLASTIC TIP, IMPEDING INTRODUCTION OF THE SYSTEM. SINCE THE MATERIAL COMPLICATIONS DID NOT AFFECT THE PRIMARY OUTCOME, THEY WERE NOT DOCUMENTED ACCORDING TO THE STUDY PROTOCOL. POSTOPERATIVELY, A FULL PHYSICAL EXAMINATION WITH A FOCUS ON NEUROLOGICAL SEQUELAE WAS DONE. THE ARTICLE NOTED NO POSTOPERATIVE SEQUELAE. NO PATIENT DEATH OR HARM WAS NOTED IN THIS ARTICLE. THIS IS 7 OF 7 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212095 VERTEBRAL AUGMENTATION ACCESS KIT LOD SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1