BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2953769-2011-00016

    MDR report key: 1988227 · Received February 14, 2011

    Report

    Report Number
    2953769-2011-00016
    Event Type
    Malfunction
    Date Received
    February 14, 2011
    Report Date
    January 19, 2011
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): METHOD - DEVICE NOT RETURNED; FOLLOWED UP WITH AUTHOR REFERENCE MFR REPORT #: 2953769-2011-00015.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE TITLED "UNILATERAL VERSUS BILATERAL BALLOON KYPHOPLASTY FOR MULTI-LEVEL OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES: A PROSPECTIVE STUDY", THAT: EXTRAVASATION OF PMMA OUTSIDE THE VERTEBRAL BODY OCCURED IN 6/49 OF PATIENTS OR 6/114 OF TREATED LEVELS. IN UNILATERAL GROUP, CEMENT LEAKED INTO THE ADJACENT DISC HAPPENED IN 1 CASE, INTO PARAVERTEBRAL VEIN IN 1 CASE. IN BILATERAL GROUP, CEMENT LEAKAGE INTO THE ADJACENT DISC HAPPENED IN 1 CASE, LEAKAGE LATERAL TO THE VERTEBRAL BODY IN 1 CASE, LEAKAGE INTO PARAVERTEBRAL VEIN IN 1 CASE, LEAKAGE INTO THE SPINAL CANAL IN 1 PATIENT. NONE OF THE CEMENT LEAKAGES HAD ANY APPARENT CLINICAL CONSEQUENCES, AND NO PATIENTS DEVELOPED NEUROLOGICAL SYMPTOMS. NO FURTHER INFORMATION WAS REPORTED. NOTE: MEDTRONIC SPINE LLC DOES NOT CURRENTLY DISTRIBUTE PRODUCT IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NDN MEDTRONIC SPINE LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1