BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 5249500 · Received November 25, 2015

    Report

    Report Number
    2953769-2015-00154
    Event Type
    Injury
    Date Received
    November 25, 2015
    Report Date
    October 26, 2015
    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

    (B)(6). (B)(4). PMA 510(K). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE CATALOG # C01A AND 510K # K041584 OF 'LIKE DEVICES' 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 OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE (B)(6) 2015, PATIENT UNDERWENT L2 BALLOON KYPHOPLASTY. POST-OP, ON AN UNKNOWN DATE, PATIENT DEVELOPED INFECTION. CRP WAS 17 WHEN THE PATIENT WAS HOSPITALIZED IN THE FACILITY WHICH WAS DECREASED TO 4 AT THE TIME OF THE REPORTING. ABSCESS WAS FOUND ALONG LEFT ILIOPSOAS AT LEVELS L2-L3. ON AN UNKNOWN DAY IN (B)(6) 2015, THE PATIENT CONSULTED DOCTOR IN THE HOSPITAL FOR BACK PAIN. ON (B)(6) 2015, THE PATIENT UNDERWENT AN ANTERIOR PROCEDURE IN WHICH BONE CEMENT WAS REMOVED AND ILIAC BONE WAS GRAFTED. REVISION SURGERY WILL BE SCHEDULED ON (B)(6) 2015 FOR POSTERIOR SPINAL FUSION (TH11, TH12, L4, AND L5).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780152 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BKP KIT