BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON HV-R BONE CEMENT

    MDR report key: 8559851 · Received April 29, 2019

    Report

    Report Number
    2953769-2019-00009
    Event Type
    Malfunction
    Date Received
    April 29, 2019
    Date of Event
    April 8, 2019
    Report Date
    April 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

    PMA/510(K): 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT PERCUTANEOUS VERTEBROPLASTY AT T11 DUE TO PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE. INTRA-OP, THE CEMENT WAS LEAKED FROM THE OUTSIDE OF THE INFERIOR END-PLATE WHEN INJECTING THE SECOND BOND FILLER DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ORIGINAL PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353460 KYPHON HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA EL70095

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR