BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON HV-R BONE CEMENT

    MDR report key: 10166216 · Received June 18, 2020

    Report

    Report Number
    2953769-2020-00008
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    May 19, 2020
    Report Date
    June 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, 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 BALLOON KYPHOPLASTY SURGERY DUE TO PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE AT L1. POST-OP, CEMENT AT L1 LEAKED TO THE LATERAL SIDE OF THE VERTEBRAL BODY. IT WAS CONFIRMED IN THE X-RAY IMAGE AFTER THE OPERATION. THE CEMENT WAS DOUGHY AND HOMOGENOUS PRIOR TO DELIVERY INTO THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635595 KYPHON HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1