BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEMENT, BONE, VERTEBROPLASTY

    MDR report key: 6510177 · Received April 21, 2017

    Report

    Report Number
    1030489-2017-00945
    Event Type
    Malfunction
    Date Received
    April 21, 2017
    Report Date
    March 27, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: YAO-SEN WU, HUI ZHANG, WEN-HAO ZHENG, ZHEN-HUA FENG, ZE-XIN CHEN, YAN LIN; "HIDDEN BLOOD LOSS AND THE INFLUENTIAL FACTORS AFTER PERCUTANEOUS KYPHOPLASTY SURGERY." MEAN AGE: 71 YEARS. GENDER: 33 MALE AND 82 FEMALE. (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH ABSTRACT THAT FROM JANUARY 2015 TO JANUARY 2016, 115 PATIENTS WITH OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES (OVCFS) WHO WERE SCHEDULED TO HAVE A PERCUTANEOUS KYPHOPLASTY (PKP) WERE ENROLLED IN THE STUDY. PATIENTS WITH SEVERE VERTEBRAL HEIGHT LOSS, BETTER VERTEBRAL HEIGHT RESTORATION, AND MULTI-SEGMENTAL VERTEBRAL FRACTURES HAD A HIGHER AMOUNT OF HBL. FRESH FRACTURES AND CEMENT LEAKAGE WERE ALSO IMPORTANT FACTORS TO INCREASE HBL, WHEREAS GENDER, AGE, BMI, HYPERTENSION, DIABETES MELLITUS, AND BMD WERE NOT CORRELATED WITH HBL. WHEN THEY COMPARED THE INCIDENCE OF ANEMIA BETWEEN PREOPERATIVE AND POST-OPERATIVE, THEY FOUND THAT THE INCIDENCE OF ANEMIA WAS SIGNIFICANTLY ASSOCIATED WITH HBL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291743 CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR