BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R? BONE CEMENT

    MDR report key: 3233863 · Received July 18, 2013

    Report

    Report Number
    2953769-2013-00109
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 19, 2013
    Manufacturer
    MDT KYPHON SUNNYVALE MFG
    Product Code
    NDN
    PMA / PMN Number
    K093828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BALLOON KYPHOPLASTY PROCEDURE (BKP) TO TREAT AN OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURE. ACCORDING TO THE REPORT, THE "PATIENT HAD PLATYSPONDYLISIS SO THAT THE CEMENT COULD NOT BE PUSHED BACK WHEN IT WAS DELIVERED IN THE CAVITIES" AND "CEMENT REMAINED IN PEDICLE". REPORTEDLY, THE CEMENT WAS NOT RUNNY WHEN IT WAS DELIVERED INTO THE PATIENT AND "HAD REACHED THE EXACT DELIVERY CONSISTENCY". THE CEMENT WAS STORED AT 23 +/- 1C FOR 24 HOURS PRIOR TO USE AND THE OPERATING ROOM TEMPERATURE WAS 24.7 C. IT WAS ALSO REPORTED THAT A MIXER WAS USED FOR 30 SECONDS AND A CDS (CEMENT DELIVERY SYSTEM) WAS USED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335830 KYPHX® HV-R? BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON SUNNYVALE MFG NA EL41912

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR BKP, BALLOONS ,CDS, MIXER