BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON HV-R BONE CEMENT

    MDR report key: 8914925 · Received August 21, 2019

    Report

    Report Number
    1030489-2019-00923
    Event Type
    Malfunction
    Date Received
    August 21, 2019
    Date of Event
    April 11, 2019
    Report Date
    August 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

    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 L3. INTRA-OP, CEMENT EXTRAVASATION OCCURRED AT INFER IOR DISC SPACE. EXTRUSION OF CEMENT WAS NOT MORE THAN 15MM; AND THIS EVENT WAS NOT DETERMINED TO BE CLINICALLY SIGNIFICANT. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS DETERMINED TO BE RELATED TO THE PROCEDURE; AND NOT RELATED TO ANY OF THE IMPLANTED DEVICES. THE OUTCOME OF THE EVENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711320 KYPHON HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC NA 216423906

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR