BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEMENT, BONE, VERTEBROPLASTY

    MDR report key: 5744264 · Received June 23, 2016

    Report

    Report Number
    1030489-2016-01870
    Event Type
    Malfunction
    Date Received
    June 23, 2016
    Report Date
    May 24, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEAN AGE: 44.8. SIXTEEN FEMALES, 36 MALE. LITERATURE CITATION: S.TEYSSEDOU, M. SAGET, L.E. GAYET, P.PRIES, C. BREQUE, T. VENDEUVRE "RADIOLOGIC STUDY OF DISC BEHAVIOR FOLLOWING COMPRESSION FRACTURE OF THE THORACOLUMBAR HINGE MANAGED BY KYPHOPLASTY: A 52-CASE SERIES." NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A TOTAL OF 52 PATIENTS WERE INCLUDED, WITH MEAN FOLLOW-UP OF 18.6 MONTHS, VK FELL FROM 13.9 DEGREES PRE-OPERATIVELY TO 8.2 DEGREES AT LAST FOLLOW-UP. DHI FOUND SIGNIFICANT SUPERIOR DISC SUBSIDENCE (P=0.0001) AND NON SIGNIFICANT INFERIOR DISC SUBSIDENCE (P=0.116). DA SHOWED SIGNIFICANTLY REDUCED SUPERIOR DISC LORDOSIS (P=4*10-5). SUPDHI CORRELATED WITH VK CORRECTION (R=0.32). PRE-OPERATIVE VK DID NOT CORRELATE WITH RADIOLOGICAL DEGENERATION OF THE ADJACENT DISC. THERE WERE 2 CASES OF CEMENT LEAKAGE IN THE INFERIOR DISC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399621 CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR