BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 8095552 · Received November 21, 2018

    Report

    Report Number
    2953769-2018-00031
    Event Type
    Malfunction
    Date Received
    November 21, 2018
    Date of Event
    November 5, 2018
    Report Date
    November 21, 2018
    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

    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. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # C01A, 510K #K041584 AND UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. 2953769-2018-00031. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS: PRIMARY OSTEOPOROSIS IT WAS REPORTED THAT INTRA-OP, BONE CEMENT SOLIDIFIED DURING INJECTION AND IT COULD NOT BE USED. A NEW PRODUCT WAS USED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATION WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935887 KYPHX HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA EL70060

    Patients

    Seq Age Sex Outcome Treatment
    1