BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 3073117 · Received April 23, 2013

    Report

    Report Number
    1030489-2013-01252
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    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) PROCEDURE AT T11. PER THE REPORT, "PART OF THE ANTERIOR WALL AND POSTERIOR WALL WERE BRITTLE." THE CEMENT WAS INJECTED 13 MINUTES FROM THE START OF MIXING, AND HAD A "STRINGY" CONSISTENCY. IT WAS REPORTED THAT "SLIGHT CEMENT LEAKAGE TOWARD SPINAL CANAL WAS CONFIRMED AT AROUND THE END OF CEMENT INJECTION" AND CEMENT INJECTION WAS IMMEDIATELY STOPPED. IT WAS NOTED THAT THERE WAS NO CHANGE IN THE PATIENT'S VITAL SIGNS AT THE TIME. IMMEDIATELY POST-OP, THE PHYSICIAN REASSESSED THE EXTRAVASATION AND IT COULD NOT BE DETECTED ON THE C-ARM, HOWEVER, CT SCANS CONFIRMED CEMENT EXTRAVASATION OCCURRED FROM THE "PEDICLE TO THE SPINAL CANAL ON THE LEFT SIDE." THE PATIENT WAS REPORTEDLY ASYMPTOMATIC AND DOING WELL. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173395 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 IBT. MIXER, CDS