BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEMENT, BONE, VERTEBROPLASTY

    MDR report key: 4204133 · Received October 27, 2014

    Report

    Report Number
    1030489-2014-04141
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 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: GUANGDONG CHEN, ZONG-PING LUO, HONGTAO ZHANG, BADRI NALAJALA, HUILIN YANG. "PERCUTANEOUS KYPHOPLASTY IN THE TREATMENT OF PAINFUL OSTEOBLASTIC METASTATIC SPINAL LESIONS". JOURNAL OF CLINICAL NEUROSCIENCE 20 (2013) 948-950. (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 JOURNAL ARTICLE THAT SIX PATIENTS WITH PAINFUL OSTEOBLASTIC METASTATIC SPINAL LESIONS UNDERWENT PKP (PERCUTANEOUS KYPHOPLASTY PROCEDURE). THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE FEASIBILITY, EFFICACY AND SAFETY OF PKP FOR THE TREATMENT OF PAINFUL OSTEOBLASTIC SPINAL METASTASES UNRESPONSIVE TO CONSERVATIVE TREATMENTS. BETWEEN MAY 2005 AND JANUARY 2012, SIX PATIENTS (THREE WOMEN AND THREE MEN) WITH A MEAN AGE OF 59.3 YEARS (RANGE, 50- 73 YEARS) AND PAINFUL OSTEOBLASTIC SPINAL METASTASES, WERE TREATED WITH PKP. THE CRITERION OF INCLUSION WAS A SIGNIFICANTLY PAINFUL SPINAL METASTASIS WITH PURE BLASTIC CHANGE, RESPONSIBLE FOR SEVERE BACK PAIN FOR AT LEAST 1 MONTH, REFRACTORY TO CONSERVATIVE TREATMENTS. INCLUDING OPIATE ANALGESIA, HORMONE THERAPY AND BISPHOSPHONATES. THE OSTEOBLASTIC LESIONS OF THE SPINE WERE CAUSED BY SECONDARY CANCERS OF THE BREAST (N=2), LUNG (N=2), LIVER (N=1) AND PROSTATE (N=1 ). THE LEVELS TREATED BY PKP WERE LOCATED IN THE THORACIC AND LUMBAR SPINE. UNDER GENERAL ANESTHESIA, A KYPHOPLASTY SYSTEM WAS USED IN ALL PATIENTS. UNDER BIPLANAR FLUOROSCOPIC GUIDANCE, A TRANSPEDICULAR APPROACH WAS UTILIZED WITH TROCAR AND CANNULA SYSTEMS PLACED THROUGH THE PEDICLES INTO THE LESIONS. POLYMETHYLMETHACRYLATE (PMMA) CEMENT WAS INJECTED INTO THE CAVITY WITHIN THE VERTEBRAL BODY WHEN IT BECAME DOUGHY AND COULD STAND AT THE TIP OF THE BONE CEMENT INSERTER. THE INJECTION PROCESS WAS MONITORED CONTINUOUSLY UNDER FLUOROSCOPIC CONTROL IN THE LATERAL PLANE. THE PROCEDURE WAS STOPPED IF IT BECAME DIFFICULT BECAUSE OF HIGH RESISTANCE OR WHEN THE PMMA REACHED THE POSTERIOR MARGIN OF THE VERTEBRAL BODY. CLINICAL EXAMINATIONS WERE PERFORMED PRIOR TO SURGERY, POSTOPERATIVELY (3 DAYS AFTER PKP), AT 1 MONTH AND 3 MONTHS AFTER PKP, AND AT THE LAST FOLLOW UP (FROM 16 TO 96 WEEKS AFTER PKP). THE AVERAGE VOLUME OF CEMENT INJECTED WAS 3.3 ± 1.0 ML. IT WAS REPORTED THAT PLAIN RADIOGRAPHS AND MULTI-SLICE CT SCANS OBTAINED POSTOPERATIVELY DEMONSTRATED ONE PATIENT HAD ASYMPTOMATIC LEAKAGE OF BONE CEMENT INTO THE ANTERIOR VERTEBRAL VEIN. DESPITE THE LEAKAGE OF PMMA, NONE OF THE PATIENTS DEVELOPED ANY RELATED CLINICAL OR NEUROLOGIC SYMPTOMS. THERE WERE NO PKP-RELATED COMPLICATIONS AFTER THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681918 CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR PKP, TROCAR, CANNULA, BALLOON, BIOPSY DEVICE