BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 6299552 · Received February 3, 2017

    Report

    Report Number
    2953769-2017-00008
    Event Type
    Injury
    Date Received
    February 3, 2017
    Date of Event
    January 10, 2017
    Report Date
    January 10, 2017
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    NDN
    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 # K041584 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. ALTHOUGH IT IS UNKNOWN IF ANY MEDTRONIC DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT UNDERWENT BALLOON KYPHOPLASTY FOR COMPRESSION FRACTURE DUE TO PRIMARY OSTEOPOROSIS. INT RA-OP, THE NURSE CUT HIS/HER FINGER BY A CUT END OF BOTTLE OF MONOMER WHILE OPENING IT. THE MONOMER BOTTLE WAS NOT DAMAGED. NO PRODUCT MALFUNCTION HAS BEEN REPORTED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WAS A DELAY OF LESS THAN 60 MINUTES AS A RESULT OF THIS EVENT. UPDATE RECEIVED ON 17 JAN 2017:

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83029 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other