BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 9719448 · Received February 18, 2020

    Report

    Report Number
    2953769-2020-00004
    Event Type
    Malfunction
    Date Received
    February 18, 2020
    Date of Event
    January 22, 2020
    Report Date
    February 18, 2020
    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 SURGERY AT T12 DUE TO PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE. INTRA-OP DURING CEMENT FILLING, THE CEMENT WAS LEAKED TO THE SIDE OF THE VERTEBRAL BODY WHEN CHECKING FROM THE FRONTAL SIDE. IT LEAKED ABOUT 0.2CC. THE VERTEBRAL BODY WAS FISH VERTEBRA AND SOLIDIFICATION WAS CHECKED. IT WAS CONSIDERED THAT THE CEMENT LEAKED BECAUSE THE BALLOON DID NOT INFLATE TOO MUCH AND THE CAVITY COULD NOT BE MADE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING THE ALLEGED PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184384 KYPHX HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA EL70122

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR