BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEMENT, BONE, VERTEBROPLASTY

    MDR report key: 4157252 · Received October 9, 2014

    Report

    Report Number
    1030489-2014-03992
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Report Date
    September 11, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION : CHONGYAN WANG; SHUNWU FAN; JUNHUI LIU; LETU SUYOU; ZHI SHAN; FENGDONG ZHAO. "BASIVERTEBRAL FORAMEN COULD BE CONNECTED WITH INTRAVERTEBRAL CLEFT: A POTENTIAL RISK FACTOR OF CEMENT LEAKAGE IN PERCUTANEOUS KYPHOPLASTY". THE SPINE JOURNAL 14 (2014) 1551-1558. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RETROSPECTIVE STUDY WAS PERFORMED ON 164 PATIENTS TO ASSESS THE INCIDENCE RATE OF DIFFERENT TYPES OF CEMENT LEAKAGE IN PKP (PERCUTANEOUS KYPHOPLASTY PROCEDURES) WITH OR WITHOUT INTRAVERTEBRAL CLEFTS AND TO DETERMINE WHETHER THE BASIVERTEBRAL FORAMEN COULD BE CONNECTED TO THE INTRAVERTEBRAL CLEFT. BETWEEN JANUARY 2009 AND JANUARY 2012, 183 PATIENTS UNDERWENT PKP TO TREAT OVCFS. ALL PATIENTS REPORTED REFRACTORY LOW BACK PAIN AND TENDERNESS, AND FAILED TO RESPOND TO CONSERVATIVE TREATMENT FOR AT LEAST 2 MONTHS; 204 VERTEBRAE IN 164 PATIENTS (129 WOMEN AND 35 MEN) WITH A MEAN AGE OF 71 YEARS (RANGE, 56-91 YEARS) WERE SELECTED FOR THE STUDY. A TOTAL OF 204 VERTEBRAE IN 164 CONSECUTIVE PATIENTS WHO UNDERWENT PKP TO TREAT OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES WERE CLASSIFIED INTO TWO PATTERNS BASED ON PREOPERATIVE RADIOGRAPHS, CT SCANS, AND/OR MR IMAGES OF THE TREATED LEVELS: CLEFT PATTERN (WITH AN INTRAVERTEBRAL CLEFT IN THE VERTEBRAL BODY) AND TRABECULAR PATTERN (WITHOUT INTRA VERTEBRAL CLEFTS). A TRABECULAR PATTERN COULD BE INFERRED IF THE OPAQUE CEMENT WAS INTERSPERSED THROUGHOUT THE TRABECULAR SPACE LIKE A SPONGE. THE OCCURRENCE AND TYPE OF CEMENT LEAKAGE WERE ASSESSED ON POSTOPERATIVE RADIOGRAPHS, CT SCANS, AND/OR MR IMAGES OF THE TREATED LEVELS. THE PATTERNS OF CEMENT LEAKAGE WERE CLASSIFIED INTO FIVE TYPES: TYPE A, THROUGH A CORTICAL DEFECT INTO PARASPINAL SOFT TISSUES; TYPE B, THROUGH THE BASIVERTEBRAL FORAMEN; TYPE C, VIA THE NEEDLE CHANNEL; TYPE D, THROUGH A CORTICAL DEFECT INTO THE DISC SPACE; AND TYPE E, VIA THE PARAVERTEBRAL VEIN. IT WAS REPORTED THAT ASYMPTOMATIC CEMENT EXTRAVASATION THROUGH A CORTICAL DEFECT INTO THE DISC SPACE (TYPE D) OCCURRED IN 14 VERTEBRAE (6.9%). THESE LEAKS WERE OBSERVED IN 12 OF 162 VERTEBRAE WITH A REGULAR TRABECULAR PATERN, AND IN 2 OF 41 VERTEBRAE WITH A CLEFT PATTERN. NO PATIENT SYMPTOMS WERE REPORTED FOR TYPE D EXTRAVASATIONS IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635751 CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR KYPHOPLASTY DEVICES