BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON HV-R BONE CEMENT

    MDR report key: 8265066 · Received January 21, 2019

    Report

    Report Number
    1030489-2019-00078
    Event Type
    Malfunction
    Date Received
    January 21, 2019
    Date of Event
    December 19, 2018
    Report Date
    January 21, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NDN
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # C01B, 510K #K041584, UPN# (B)(4) WAS CLEARED IN THE UNITED STATES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PROCEDURE: VERTEBROPLASTY (CEMENTOPLASTY WAS PERFORMED DURING PROCEDURE) IT WAS REPORTED THAT ON INTRA-OP, THE CEMENT EXTRAVASATION HAD OCCURRED AT PARASPINAL TISSUES. BONE CEMENT VOLUME IMPLANTED WAS 6 CC. PATIENT OUTCOME HAS NOT BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57707 KYPHON HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC NA 0009248207

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR