BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHON HV-R BONE CEMENT

    MDR report key: 10060229 · Received May 15, 2020

    Report

    Report Number
    2953769-2020-00007
    Event Type
    Injury
    Date Received
    May 15, 2020
    Date of Event
    April 15, 2020
    Report Date
    May 15, 2020
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    NDN
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER - CEMENT LEAKED TO SOMATIC ARTERIES. THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG # C01A, 510K# K180700 AND UDI (B)(4) IS APPROVED FOR SALE IN US. 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 BALLOON KYPHOPLASTY SURGERY AT L2 AFTER 1 WEEK OF COMPRESSION FRACTURE AND PRIMARY OSTEOPOROSIS. INTRA-OP, AFTER CEMENT FILLING WAS COMPLETED, CHECKING WAS PERFORMED WITH C-ARM. AFTER THAT, CEMENT SHADOW OF ABOUT 1CM WAS CHECKED ON THE LEFT SIDE OF THE VERTEBRAL BODY. WHEN RADIOGRAPH WAS CHECKED AFTER THE OPERATION, CEMENT SHADOW WAS CHECKED ON THE BLOOD VESSEL WHICH WAS CONSIDERED TO BE SOMATIC ARTERIES. ABOUT 10 MINUTES AFTER CEMENT STIRRING, CEMENT WAS TAPPED WITH FINGERS AND THREADS COULD NOT BE SEEN ANYMORE, AND IT WAS JUDGED THAT THE CEMENT VISCOSITY WAS APPROPRIATE. MOREOVER, IT WAS CHECKED THAT THE CEMENT DID NOT LEAK TO THE VERTEBRAL BODY ENDPLATE, AND DID NOT LEAK TO THE ANTERIOR AND POSTERIOR SIDE AS WELL. ON THE FOLLOWING DAY OF THE OPERATION DATE, THE PATIENT¿S SYMPTOMS DUE TO COMPRESSION FRACTURE IMPROVED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THERE WAS NO PATIENT'S CONDITION WORSEN AFTER THAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526456 KYPHON HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA EL70129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other