BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEMENT, BONE, VERTEBROPLASTY

    MDR report key: 6510529 · Received April 21, 2017

    Report

    Report Number
    1030489-2017-00956
    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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: MAX MARKMILLER; " PERCUTANEOUS BALLOON KYPHOPLASTY OF MALIGNANT LESIONS OF THE SPINE: A PROSPECTIVE CONSECUTIVE STUDY IN 115 PATIENTS." MEAN PATIENT AGE: 68.7± 11.04 YEARS. GENDER: FEMALE (MEN 42, 74 WOMEN). : 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

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PROCEDURE: BALLOON KYPHOPLASTY (BKP) IT WAS REPORTED THAT ON AN UNKNOWN DATE, OVERALL, 115 PATIENTS (52.2 % WITH VERTEBRAL FRACTURES) RECEIVED BKP SURGERY. THE MAJORITY (82.6 %) OF PATIENTS RECEIVED BKP AS A STAND-ALONE PROCEDURE. BKP TREATMENT PROVIDED SIGNIFICANT IMPROVEMENTS IN VISUAL ANALOGUE SCALE (VAS)-PAIN (MEDIAN CHANGE: -4), OSWESTRY DISABILITY INDEX (ODI; MEAN CHANGE: -53.2), AND KARNOFSKY PERFORMANCE STATUS (KPS; MEDIAN CHANGE: 15) SCORES AT 6 AND 12 MONTHS. IN TOTAL, 23 % OF PATIENTS ACHIEVED INCREASED VERTEBRAL HEIGHT (7.4 % MEAN IMPROVEMENT IN ANGLE INDEX). THE PRESENCE OF HEIGHT RESTORATION AND THE NUMBER OF LEVELS TREATED DID NOT AFFECT VAS OR ODI SCORES; IMPROVEMENTS IN KPS SCORES WERE NUMERICALLY HIGHER IN PATIENTS WHO RECEIVED BKP PLUS ADDITIONAL SURGERY (15¿20) COMPARED WITH STAND-ALONE BKP (10¿15). MEAN HOSPITAL TIMES WERE 7.2 ± 6.5 DAYS. INCIDENCES OF CEMENT LEAKAGE WERE OBSERVED IN 40 PATIENTS (34.8 %). SPECIFIC AREAS AFFECTED BY CEMENT LEAKAGE WERE IN THE VASCULAR FOR 4 CASES (3.5 %).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291781 CEMENT, BONE, VERTEBROPLASTY CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR