BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON HV-R BONE CEMENT

    MDR report key: 8675116 · Received June 6, 2019

    Report

    Report Number
    1030489-2019-00606
    Event Type
    Malfunction
    Date Received
    June 6, 2019
    Date of Event
    May 7, 2019
    Report Date
    June 6, 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

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # C01B, 510K # K180700 AND UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED PER CLINICAL STUDY THAT THE PATIENT UNDERWENT VERTEBROPLASTY AT T12. INTRA-OP, CEMENT EXTRAVASATION OCCURRED WHEN CEMENT WAS BEING IMPLANTED AT SUPERIOR DISC SPACE. CEMENT EXTRAVASATION WAS DETERMINED NOT TO BE CLINICALLY SIGNIFICANT. BONE CEMENT VOLUME IMPLANTED WAS 4CC. SPONSOR ASSESSMENT DETERMINED THAT THE PROCEDURE WAS RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470255 KYPHON HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC NA 217227824

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR