BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHON HV-R BONE CEMENT

    MDR report key: 8955406 · Received September 3, 2019

    Report

    Report Number
    1030489-2019-00969
    Event Type
    Injury
    Date Received
    September 3, 2019
    Date of Event
    August 5, 2019
    Report Date
    September 3, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NDN
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 #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

    PRE-OPERATIVE DIAGNOSIS: PRIMARY OSTEOPOROSIS TYPE OF FRACTURE: COMPRESSION FRACTURE IT WAS REPORTED THAT INTRA-OP, WHILE FILLING THE BONE CEMENT INTO THE VERTEBRAL BODY, THE CEMENT LEAKED TO THE ANTERIOR SIDE OF THE VERTEBRAL BODY. CEMENT FILLING WAS STOPPED IMMEDIATELY AND THE PROCEDURE WAS COMPLETED. THE CEMENT WAS MIXED IN MIXER FOR ABOUT 45-50 SECONDS AND WAS IN AN APPROPRIATE CONDITION BEFORE INJECTING IT INTO THE PATIENT. THE CEMENT THAT LEAKED TO THE ANTERIOR SIDE ENTERED THE BLOOD VESSEL AND REACHED PULMONARY VEIN AND PULMONARY ARTERY. WARFARIN AND LIXIANA MEDICATIONS WERE GIVEN TO THE PATIENT TO PREVENT FROM THROMBUS. REPORTEDLY, THE PATIENT IS HEALTHY CURRENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750893 KYPHON HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC NA EL70110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other