BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 8648988 · Received May 29, 2019

    Report

    Report Number
    2953769-2019-00010
    Event Type
    Malfunction
    Date Received
    May 29, 2019
    Date of Event
    May 11, 2019
    Report Date
    May 29, 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, UDI# (B)(4) WAS CLEARED IN THE UNITED STATES. PRODUCT WAS NOT 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

    PATIENT WAS DIAGNOSED WITH VERTEBRAL FRACTURE IN THE ACUTE PHASE AND UNDERWENT PERCUTANEOUS KYPHOPLASTY (SURGICAL APPROACH) AT TH12. INTRA-OP WHILE INJECTING THE CEMENT INTO BONE FILLER DEVICE, THE CEMENT SOLIDIFIED EARLIER THAN USUAL. CEMENT WAS IMPLANTED AS IT WAS. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442815 KYPHX HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA EL70095

    Patients

    Seq Age Sex Outcome Treatment
    1