BEUDAMED
    FDA Adverse Event Other Summary report: N

    KRYPTONITE-X RADIOPAQUE LIQUID BONE COMPLEX

    MDR report key: 1652375 · Received April 5, 2010

    Report

    Report Number
    1226001-2010-00011
    Event Type
    Other
    Date Received
    April 5, 2010
    Date of Event
    October 22, 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 Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE SEVERAL FACTORS THAT MAY HAVE PLAYED A ROLE IN CREATING AN INFECTION, INCLUDING BUT NOT LIMITED TO; SURGICAL PROCEDURE, IMPROPERLY STERILIZED SURGICAL INSTRUMENTATION, PERSONNEL, OR DEVICE. ADDITIONALLY, KRYPTONITE-X IS CONTRAINDICATED FOR "USE IN A CURRENTLY INFECTED FIELD OR SURGICAL SITE LOCATED NEAR AN INFECTION" AND "USE IN PATIENTS WITH THE FOLLOWING: C) A RECENT UNTREATED INFECTION". NO DOCUMENTATION WITHIN THE DHR WAS FOUND THAT INDICATES A NONCONFORMANCE THAT COULD HAVE 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 FEMORAL BONE CYST CASE, IN WHICH KRYPTONITE-X RADIOPAQUE LIQUID BONE COMPLEX WAS USED, REQUIRED A REVISION SURGERY DUE TO AN INFECTION. THE SURGEON INDICATED THAT HE WAS ABLE TO REMOVE SEGMENTS OF KRYPTONITE-X MATERIAL THAT WERE PUTTY IN CONSISTENCY.

    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 08192009

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN