BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYMETHYLMETHACRYLATE BONE CEMENT

    MDR report key: 6562726 · Received May 12, 2017

    Report

    Report Number
    3000270450-2017-10163
    Event Type
    Injury
    Date Received
    May 12, 2017
    Report Date
    April 24, 2017
    Manufacturer
    SYNTHES SELZACH
    Product Code
    NDN
    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. BROSSARD, P; ET AL (2016) ABSTRACTS FOR SFCR ¿ AUGUST: COMPARATIVE RADIOLOGICAL STUDY OF KYPHOPLASTY VERSUS STENTOPLASTY IN NON-OSTEOPOROTIC FRACTURES OF THE THORACOLUMBAR JOINT: SERIES OF 48 CASES. 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

    THE REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: BROSSARD, P; ET AL (2016) ABSTRACTS FOR SFCR ¿ AUGUST: COMPARATIVE RADIOLOGICAL STUDY OF KYPHOPLASTY VERSUS STENTOPLASTY IN NON-OSTEOPOROTIC FRACTURES OF THE THORACOLUMBAR JOINT: SERIES OF 48 CASES. EUR SPINE J, 25:2317-2342. THIS IS A PROSPECTIVE, SINGLE CENTRE AND CONTINUOUS STUDY OF 48 PATIENTS (AVERAGE AGE OF 47.3 YEARS) WAS CARRIED OUT BETWEEN OCTOBER 2011 AND NOVEMBER 2014. THE MAIN INCLUSION CRITERION WAS A RECENT NON-OSTEOPOROTIC FRACTURE OF THE THORACOLUMBAR JOINT. ONE GROUP WAS TREATED BY KYPHOPLASTY (KYPHON_ - MEDTRONIC) AND THE OTHER BY STENTOPLASTY (VBS_ ¿ SYNTHES). FILLING WAS CARRIED OUT USING HIGH-VISCOSITY PMMA CEMENT, RESPECTIVELY BIOMET BONE CEMENT V (BIOMET) AND VERTECEM V+ (SYNTHES). THE MAIN CRITERION WAS THE CORRECTION OF VERTEBRAL KYPHOSIS (VK) POST-SURGERY AND AT 3 MONTHS. THE AVERAGE REDUCTION IN VK AT 3 MONTHS WAS 4.73 DEGREE ± 4.8 DEGREE AFTER KYPHOPLASTY AND 4.63 DEGREE ± 2.7 DEGREE AFTER STENTOPLASTY (P = 0.9393). THERE WAS NO DIFFERENCE BETWEEN THE TWO TECHNIQUES FOR THE RESTORATION OF VERTEBRAL HEIGHT; THE FARCY AND BECK INDICES AND THE SETTLEMENT PERCENTAGE. THE CEMENT LEAKS WERE SIGNIFICANTLY MORE NUMEROUS (P = 0.00233) IN KYPHOPLASTY (41.7 %) THAN IN STENTOPLASTY (4.2 %). IN THE KYPHOPLASTY GROUP, WE FOUND A HIGHER RATE OF CEMENT LEAKS WITH A POTENTIAL IMPACT ON THE DISK. THIS HIGHLY SIGNIFICANT DIFFERENCE MAY BE EXPLAINED BY A POTENTIAL DIFFERENCE IN VISCOSITY BETWEEN THE 2 CEMENTS AND BY THE SINGULARITY OF THE STENT, RESPONSIBLE FOR A BRAKE ON POURING. THIS IS 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN VERTECEM V+ CEMENT AND REFERS TO THE SERIOUS INJURY / REPORTABLE MALFUNCTION OF UNKNOWN PATIENTS WHO EXPERIENCED CEMENT LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344592 POLYMETHYLMETHACRYLATE BONE CEMENT NDN SYNTHES SELZACH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention