BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX® HV-R? BONE CEMENT

    MDR report key: 3870143 · Received June 12, 2014

    Report

    Report Number
    1030489-2014-02741
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NDN
    PMA / PMN Number
    K093828
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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) AT L2. IT WAS REPORTED THAT THE PATIENT BEGAN "EXPERIENCING BILATERAL THIGH PAIN AND AFTER REVIEWING CT IMAGES THERE WAS CEMENT PRESENT IN THE SPINAL CANAL FROM THE KYPHOPLASTY PROCEDURE". THE PATIENT WAS REPORTEDLY "A TUMOR CASE AND HAD IRREGULAR BONE WHICH WAS BELIEVED TO MAKE THEM MORE PRONE TO A LEAK". THE PATIENT IS CURRENTLY BEING TREATED WITH STEROIDS TO ALLEVIATE SWELLING AND RESOLVE PAIN. AFTER REVIEWING IMAGES, THE CEMENT APPEARED TO HAVE "TRAVELLED BACK THOROUGH THE PEDICLE ON THE RIGHT SIDE AND LEAKED INTO THE POSTERIOR OF THE CANAL THROUGH A DEFECT IN THE PEDICLE". NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348484 KYPHX® HV-R? BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BKP