BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 5877815 · Received August 16, 2016

    Report

    Report Number
    2953769-2016-00060
    Event Type
    Injury
    Date Received
    August 16, 2016
    Date of Event
    July 14, 2016
    Report Date
    July 19, 2016
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    NDN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # C01A, 510K # K041584 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. ALTHOUGH IT IS UNKNOWN IF ANY MEDTRONIC DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, PATIENT COMPLAINED OF RIB PAIN. PATIENT HAD UNDERGONE BALLOON KYPHOPLASTY AT L1, ON (B)(6) 2016, FOR COMPRESSION FRACTURE DUE TO OSTEOPOROSIS. A SMALL LEAK OF THE CEMENT WAS OBSERVED FROM THE UPPER END PLATE. ALSO, THE CEMENT HAD NOT ACHIEVED STABILITY ON THE BONE AND HAD MIGRATED. THE SURGEON CONSIDERED THAT THERE WAS NO CAUSALITY BETWEEN THE EVENT AND PRODUCT. PATIENT ISSUE IS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531591 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA EL57516

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other