BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 9196528 · Received October 16, 2019

    Report

    Report Number
    2953769-2019-00018
    Event Type
    Malfunction
    Date Received
    October 16, 2019
    Date of Event
    September 18, 2019
    Report Date
    October 16, 2019
    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

    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 PERCUTANEOUS KYPHOPLASTY (BKP) AT T12 DUE TO PRIMARY OSTEOPOROSIS (COMPRESSION FRACTURE). INTRA-OP, AT THE TIME OF FILLING THE CEMENT WHILE CHECKING THE SAGITTAL AND FRONTAL IMAGE, IT WAS FOUND THAT THE CEMENT HAD LEAKED FROM THE RIGHT LATERAL WALL. FILLING OF CEMENT WAS STOPPED AT THAT STAGE. THE PROCEDURE WAS HOWEVER COMPLETED WITH THE SAME CEMENT; AND NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994087 KYPHX HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA EL70110

    Patients

    Seq Age Sex Outcome Treatment
    1