BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON HV-R BONE CEMENT

    MDR report key: 9283593 · Received November 6, 2019

    Report

    Report Number
    1030489-2019-01276
    Event Type
    Malfunction
    Date Received
    November 6, 2019
    Date of Event
    October 2, 2019
    Report Date
    November 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 A CLINICAL STUDY THAT THE PATIENT UNDERWENT VERTEBROPLASTY PROCEDURE AT L3/L4 LEVELS. DURING SURGERY, CEMENT EX TRAVASATION OCCURRED. NO PATIENT COMPLICATIONS WERE REPORTED DURING THIS EVENT. BONE CEMENT VOLUME IMPLANTED WAS 5 CC AND THE LOCATION OF EXTRAVASATION WAS FOUND TO BE AT THE INFERIOR DISK SPACE. CEMENT EXTRUSION WAS NOT GREATER THAN 15MM; AND WAS DETERMINED TO BE CLINICALLY INSIGNIFICANT. INVESTIGATOR NOTED THAT THE RELATEDNESS OF THE EVENT WAS PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081612 KYPHON HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC NA 217996667

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR