BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEMENT, BONE, VERTEBROPLASTY

    MDR report key: 2762544 · Received September 27, 2012

    Report

    Report Number
    2953769-2012-00141
    Event Type
    Injury
    Date Received
    September 27, 2012
    Report Date
    August 29, 2012
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NDN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE CITATION: LI-JUN WANG MD; HUI-LIN WANG MD, PHD; YUAN-XIN SHI MD; WEI-MIN JIANG MD; LIANG CHEN MD. PULMONARY CEMENT EMBOLISM ASSOCIATED WITH PERCUTANEOUS VERTEBROPLASTY OR KYPHOPLASTY: A SYSTEMATIC REVIEW. ORTHOPAEDIC SURGERY 2012; 4: 182-189. DATE OF EVENT IS UNKNOWN. ALTHOUGH, IT IS UNKNOWN IF PMMA CEMENT CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYSTEMATIC REVIEW OF PULMONARY CEMENT EMBOLISM (PCE) ASSOCIATED WITH PERCUTANEOUS VERTEBROPLASTY (PVP) OR PERCUTANEOUS KYPHOPLASTY (PKP) WAS CONDUCTED TO SUMMARIZE INCIDENCE, CLINICAL FEATURES, PROPHYLAXIS AND THERAPEUTIC MANAGEMENT OF PCE AFTER VERTEBRAL CEMENT REINFORCEMENT. IT WAS REPORTED THAT AMONG FIVE OBSERVATIONAL STUDIES CONSISTING OF THREE RETROSPECTIVE STUDIES AND TWO PROSPECTIVE STUDIES, ONE CASE OF CEMENT PULMONARY EMBOLISM OCCURRED FOLLOWING A PKP. NO FURTHER INFORMATION WAS REPORTED. THE TYPE OF CEMENT WAS NOT IDENTIFIED IN THE LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SPINE LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening BKP BALLOONS