BEUDAMED
    FDA Adverse Event Other Summary report: N

    KRYPTONITE BONE CEMENT

    MDR report key: 2576938 · Received May 13, 2010

    Report

    Report Number
    1226001-2010-00014
    Event Type
    Other
    Date Received
    May 13, 2010
    Date of Event
    February 10, 2010
    Report Date
    May 12, 2010
    Manufacturer
    DOCTOR'S RESEARCH GROUP, INC.
    Product Code
    GXP
    PMA / PMN Number
    K091382
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT CLEAR WHAT MAY HAVE CONTRIBUTED TO THIS EVENT AND MAY HAVE BEEN A COMPLICATION OF SURGERY. THE OBSERVED MATERIAL CONSISTENCY, 'VERY HARD CLAY', IS LIKELY THE RESULT OF THE EXCESSIVE CEREBRAL FLUID NOTED BY THE SURGEON DURING THE INITIAL SURGERY. THE PRODUCT INSTRUCTIONS CLEARLY STATE THAT THE SURGICAL WOUND AREA MUST BE DRY FOR BEST PERFORMANCE OF THE PRODUCT. THE USE OF KRYPTONITE BONE CEMENT IN SPINAL APPLICATIONS IS CONSIDERED OFF-LABEL USE. NO DOCUMENTATION WITHIN THE DHR WAS FOUND THAT WOULD INDICATE A NONCONFORMANCE TO SPECIFICATION THAT COULD HAVE CONTRIBUTED TO THIS EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT A LARGE MULTILEVEL LUMBAR SPINAL FIXATION WHERE KRYPTONITE BONE CEMENT WAS USED AS AN ADJUNCT TO SCREW AND ROD FIXATION. THE KRYPTONITE WAS APPLIED TO THE SPINAL SCREWS AND ALONG THE LATERAL GUTTERS. A REVISION WAS PERFORMED DUE TO THE DEVELOPMENT OF A SIGNIFICANT CEREBROSPINAL FLUID (CSF) LEAK. THE CSF LEAK WAS CONSIDERED TO BE ABNORMAL IN NATURE DUE TO THE EXCESSIVE AMOUNT OF CSF FLUID LEAKING FROM THE SITE. WHILE REVISING THE SITE, IT WAS NOTED THAT THE KRYPTONITE CEMENT WAS NOT AS HARD AS EXPECTED. THE SURGEON NOTED THAT THE MATERIAL WAS NOT PUTTY LIKE, BUT A VERY HARD CLAY. THE SITE LOCATION AND ANTERIOR APPROACH MADE SITE PREPARATION DIFFICULT IN THE CONTROLLING BLEEDING AND CS FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KRYPTONITE BONE CEMENT BONE CEMENT GXP DOCTOR'S RESEARCH GROUP, INC. KRYP-US-Z-10 11252009

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK