BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON HV-R BONE CEMENT

    MDR report key: 8952934 · Received September 1, 2019

    Report

    Report Number
    1030489-2019-00961
    Event Type
    Malfunction
    Date Received
    September 1, 2019
    Date of Event
    August 2, 2019
    Report Date
    September 1, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NDN
    PMA / PMN Number
    SEE H10
    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

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH L1 VERTEBRAL BODY COLLAPSE. IT WAS A COMPRESSION FRACTURE DUE TO OSTEOPOROSIS. BALLOON KYPHOPLASTY WAS PERFORMED AT L1. INTRA-OP, AFTER THE CEMENT WAS FILLED INTO L1 VERTEBRAL BODY, IT WAS FOUND THAT THE CEMENT LEAKED TO THE LATERAL SIDE OF THE RIGHT VERTEBRAL BODY. ACCORDING TO THE SURGEON, THERE WERE NO PROBLEMS DUE TO THE EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746738 KYPHON HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1