BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 5235224 · Received November 19, 2015

    Report

    Report Number
    2953769-2015-00151
    Event Type
    Malfunction
    Date Received
    November 19, 2015
    Date of Event
    October 21, 2015
    Report Date
    October 21, 2015
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4) PMA 510(K): 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT BALLOON KYPHOPLASTY PROCEDURE TO TREAT COMPRESSION FRACTURE. DURING PROCEDURE, THE SURGEON INSERTED TOO MUCH BONE CEMENT THAT THE CEMENT FLEW BACK TO THE PEDICLE INLET. PROTRUDED CEMENT WAS REMOVED AND SURGERY WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766765 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1