BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 7977034 · Received October 18, 2018

    Report

    Report Number
    2953769-2018-00029
    Event Type
    Malfunction
    Date Received
    October 18, 2018
    Date of Event
    September 19, 2018
    Report Date
    October 18, 2018
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    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

    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. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # C01A, 510K #K041584 AND UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. 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 KYPHOPLASTY SURGERY DUE TO METASTATIC BONE TUMORS. INTRA-OP, THE CEMENT FILLED INTO THE LEFT SIDE OF L1 VERTEBRAL BODY LEAKED A LITTLE. THERE WAS A DELAY OF LESS THAN 60 MIN IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819167 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA EL70060

    Patients

    Seq Age Sex Outcome Treatment
    1