BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEMENT, BONE, VERTEBROPLASTY

    MDR report key: 3002007 · Received March 13, 2013

    Report

    Report Number
    1030489-2013-00736
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 11, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NDN
    PMA / PMN Number
    K093828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: K. YOKOYAMA, M. KAWANISHI, M. YAMADA, H. TANAKA, Y. ITO, M. HIRANO, AND T. KUROIWA. "IN NOT ONLY VERTEBROPLASTY BUT ALSO KYPHOPLASTY, THE RESOLUTION OF VERTEBRAL DEFORMITIES DEPENDS ON VERTEBRAL MOBILITY". AMERICAN JOURNAL OF NEURORADIOLOGY 2013; (10.3174/AJNR.A3424). AGE OF PATIENTS INCLUDED IN THE STUDY WAS 75.5 +/- 6.3 YEARS. SIX MALE AND 32 FEMALE PARTICIPANTS. DATE OF EVENT IS UNKNOWN. (B)(6). (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A RETROSPECTIVE STUDY THAT 38 PATIENTS/43 VERTEBRAL BODIES (VBS) WITH OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES (VCFS) WERE TREATED WITH BALLOON KYPHOPLASTY (BKP) AND 28 PATIENTS/34 VBS WITH OSTEOPOROTIC VCFS WERE TREATED WITH VERTEBROPLASTY. ALL PATIENTS WERE OPERATED ON BY THE SAME SURGEON. SURGERIES WERE PERFORMED WITH THE PATIENTS UNDER LOCAL ANESTHESIA IN PRONE POSITION. IN ALL CASES, BALLOON KYPHOPLASTY WAS PERFORMED THROUGH THE TRANSPEDICULAR ROUTE ON BOTH SIDES BY PLACEMENT OF WORKING CANNULAS BILATERALLY BY USING STANDARD KYPHOPLASTY EQUIPMENT. IN THE VERTEBRAL BODY, THE BALLOONS ON EACH SIDE WERE INFLATED TO CREATE A SPACE FOR INJECTION OF THE BONE CEMENT, AND THEN THE BALLOONS WERE DEFLATED AND REMOVED. THE PMMA MIXTURE WAS ALSO INJECTED INTO THE VERTEBRAL BODY FROM BOTH SIDES. WHEN THE BONE CEMENT CONTACTED SOME PART OF CORTICAL MARGIN OF THE VERTEBRAL BODY, THE SURGERY WAS COMPLETED BY WITHDRAWING THE NEEDLES. DURING THE BONE CEMENT INJECTION, FLUOROSCOPIC MONITORING WAS CONDUCTED IN BOTH PLANES WITH A C-ARM UNIT. THE VOLUME OF INJECTED CEMENT WAS 2.5 +/- 1.0 ML FOR THE KYPHOPLASTY GROUP. DURING BOTH VERTBROPLASTY AND KYPHOPLASTY PROCEDURES, INJECTION OF BONE CEMENT WAS DISCONTINUED WHEN IT APPROACHED SOME PART OF CORTICAL MARGIN OF THE FRACTURED VERTEBRAL BODY. IT WAS REPORTED THAT "BONE CEMENT LEAKED" INTO THE DISK SPACE IN FOUR CASES FROM THE BALLOON KYPHOPLASTY GROUP. NO OTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105843 CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR BKP