BEUDAMED
    FDA Adverse Event Other Summary report: N

    KRYPTONITE-X RADIOPAQUE LIQUID BONE COMPLEX

    MDR report key: 1652374 · Received April 5, 2010

    Report

    Report Number
    1226001-2010-00012
    Event Type
    Other
    Date Received
    April 5, 2010
    Date of Event
    December 14, 2009
    Report Date
    March 22, 2010
    Manufacturer
    DOCTOR'S RESEARCH GROUP, INC.
    Product Code
    GXP
    PMA / PMN Number
    K091382
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE SEVERAL FACTORS THAT MAY HAVE PLAYED A ROLE IN NOT ALLOWING THE KRYPTONITE-X MATERIAL TO FULLY HARDEN, INCLUDING BUT NOT LIMITED TO; INSUFFICIENT OR IMPROPER SITE PREPARATION, TOO MUCH BLOOD WITHIN SURGICAL SITE, OR IMPROPER MIXING. FOLLOW-UP INFORMATION INDICATED THAT KRYPTONITE-X WAS IMPLANTED INTO A SITE WHICH WAS BLOODY. IT WAS ADDITIONALLY INDICATED BY THE SURGEON THAT IMPROPER SITE PREPARATION, AS WELL AS, THIS BEING HIS FIRST CASE MAY HAVE ALSO CONTRIBUTED TO THIS EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE IDENTIFIED PRODUCT AND PRODUCT CODE IS DESIGNATED FOR EXPORT ONLY.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT A CRANIOTOMY ON (B)(6) 2009, WITHOUT NOTED ISSUES. A REVISION SURGERY WAS LATER PERFORMED IN (B)(6) 2009 DUE TO THE PATIENT PRESENTING WITH PURULENT PHLOGOSIS ALONG THE SCAR, IN CORRESPONDENCE WITH THE HOLES PRODUCED BY THE CRANIOTOMY FILLED WITH KRYPTONITE-X MATERIAL. THE KRYPTONITE-X MATERIAL WAS REMOVED USING BONE NIPPERS AND WAS FOUND TO NOT BE COMPLETELY SOLID, BUT STILL SOMEWHAT ELASTIC. THE KRYPTONITE-X MATERIAL DID NOT ADHERE TO THE CRANIC THECA AND IT WAS REMOVED EASILY. IT WAS THE OPINION OF THE SURGEON THAT THE PHLOGOSIS (INFLAMMATION) WAS GENERATED BY KRYPTONITE CONSIDERING IT LIKE A MATERIAL EXTRANEOUS TO THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KRYPTONITE-X RADIOPAQUE LIQUID BONE COMPLEX BONE CEMENT GXP DOCTOR'S RESEARCH GROUP, INC. KRYP-X-10 10282008

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK