BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHON HV-R BONE CEMENT

    MDR report key: 6975566 · Received October 25, 2017

    Report

    Report Number
    2953769-2017-00113
    Event Type
    Injury
    Date Received
    October 25, 2017
    Date of Event
    September 27, 2017
    Report Date
    October 25, 2017
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    NDN
    PMA / PMN Number
    SEE H10
    Adverse Event
    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 # K160983 AND (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. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BALLOON KYPHOPLASTY PROCEDURE, WHILE PERFORMING AMPULE-CUT ON THE BOTTLE OF THE CEMENT, THE NURSE CUT HER THUMB. THE PRODUCT DID NOT COME IN CONTACT WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756545 KYPHON HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA EL62216

    Patients

    Seq Age Sex Outcome Treatment
    1 Other