BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 1741409 · Received June 28, 2010

    Report

    Report Number
    2953769-2010-00219
    Event Type
    Injury
    Date Received
    June 28, 2010
    Date of Event
    May 19, 2010
    Report Date
    June 9, 2010
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    NDN
    PMA / PMN Number
    K041584
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED; FOLLOWED UP WITH COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A BALLOON KYPHOPLASTY PROCEDURE AT LWK 3. INTRAOPERATIVELY, IT WAS OBSERVED THAT THE BONE CEMENT LEAKED INTO THE RIGHT AND LEFT SIDE AND INTO THE DISC. POST-PROCEDURE, THE PT HAD A ULTRASOUND PERFORMED DUE TO INGUINAL PAIN. IN ADDITION, AN X-RAY WAS PERFORMED DUE TO THE PT'S WORSENING PAIN. ON (B)(6) 2010, A CT SCAN WAS PERFORMED AND ABSCESSES ON BOTH SIDES WERE OBSERVED. ON (B)(6) 2010 AN MRI, CT, PUNCTURE AND FLUSHING WERE PERFORMED. IT WAS NOTED THAT COAGULASE-NEGATIVE STAPHYLOCOCCUS AUREUS WAS FOUND. NO ADDITIONAL INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHX HV-R BONE CEMENT HIGH VISCOSTIY, RADIOPAQUE BONE CEMENT NDN MEDTRONIC SPINE LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention