BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON HV-R BONE CEMENT

    MDR report key: 9518171 · Received December 26, 2019

    Report

    Report Number
    1030489-2019-01480
    Event Type
    Malfunction
    Date Received
    December 26, 2019
    Date of Event
    November 21, 2019
    Report Date
    December 26, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # C01B, 510K # K041584, 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 VIA OPUS ONE STUDY THAT PATIENT UNDERWENT VERTEBROPLASTY SURGERY DUE TO UNKNOWN REASON. INTRA-OP, CEMENT EXTRAVASATION OCCURRED. PATIENT COMPLICATION ARE UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314001 KYPHON HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC NA 218228361

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR