BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON HV-R BONE CEMENT

    MDR report key: 8549053 · Received April 25, 2019

    Report

    Report Number
    1030489-2019-00472
    Event Type
    Malfunction
    Date Received
    April 25, 2019
    Date of Event
    March 29, 2019
    Report Date
    April 25, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NDN
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # C01A, 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 THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY DUE TO OSTEOPOROTIC FRACTURE. INTRA-OP, CEMENT WAS REPORTED TO BE VERY RUNNY EVEN AFTER WAITING FOR 20 MINUTES. THE CEMENT WAS STILL IMPLANTED IN THE PATIENT. NO EXTRAVASATION OF CEMENT WAS NOTED IN THE PATIENT AND NO ADVERSE EVENT WAS REPORTED. THERE WAS A DELAY IN OVERALL PROCEDURE TIME DUE TO THIS EVENT; BUT NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341373 KYPHON HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC NA EL70103

    Patients

    Seq Age Sex Outcome Treatment
    1