BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 6306433 · Received February 7, 2017

    Report

    Report Number
    2953769-2017-00011
    Event Type
    Malfunction
    Date Received
    February 7, 2017
    Date of Event
    January 13, 2017
    Report Date
    January 13, 2017
    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

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE CATALOG # C01A AND 510K # K160983 IS CLEARED IN THE UNITED STATES. (B)(4). 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.

    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 PATIENT WITH METASTATIC BONE TUMOR AT L1 AND VERTEBRAL COMPRESSION FRACTURE UNDERWENT SURGERY. INTRA-OP, CEMENT FLOWED TO THE LOWER VERTEBRAL BODY DURING FILLING OF CEMENT FROM RIGHT SIDE AND CEMENT LEAKED TO INTER-VERTEBRAL DISC. THE CEMENT WAS STORED AT PROPER TEMPERATURE BEFORE AND DURING THE PROCEDURE. THE CEMENT WAS MIXED FOR ABOUT ONE MINUTE. IT WAS DOUGHY AND HOMOGENEOUS PRIOR TO DELIVERY INTO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ORIGINAL PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91191 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA EL56015

    Patients

    Seq Age Sex Outcome Treatment
    1