BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON HV-R BONE CEMENT

    MDR report key: 9878324 · Received March 25, 2020

    Report

    Report Number
    9612164-2020-01349
    Event Type
    Malfunction
    Date Received
    March 25, 2020
    Date of Event
    March 3, 2020
    Report Date
    March 25, 2020
    Manufacturer
    MEDTRONIC MEXICO
    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 UNDERWENT BALLOON KYPHOPLASTY AT L1. INTRA-OP, FIVE MINUTES AFTER CEMENT MIXING, THE CEMENT SOLIDIFIED WHEN IT WAS BEING INJECTED INTO THE BONE FILLER DEVICE. REPORTEDLY, THE CEMENT SOLIDIFIED EARLIER THAN USUAL. HENCE, THE KIT, THE MIXER AND THE CEMENT WERE REPLACED WITH NEW ONES; AND THE OPERATION WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345150 KYPHON HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC MEXICO NA EL70129

    Patients

    Seq Age Sex Outcome Treatment
    1