BEUDAMED
    FDA Adverse Event Other Summary report: N

    KRYPTONITE BONE CEMENT

    MDR report key: 2428918 · Received January 20, 2012

    Report

    Report Number
    1226001-2011-00004
    Event Type
    Other
    Date Received
    January 20, 2012
    Date of Event
    December 12, 2011
    Report Date
    January 19, 2012
    Manufacturer
    DOCTOR'S RESEARCH GROUP, INC.
    Product Code
    GXP
    PMA / PMN Number
    K091382
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TESTED KRYPTONITE MATERIAL PERFORMANCE WAS CONSISTENT WITH EXPECTATION AND DOES NOT SUGGEST A NON-CONFORMANCE. NO NOTICEABLE DIFFERENCES (I.E., VISCOSITY, MIXING, ETC.) WERE OBSERVED WITH THE SUSPECT KITS. THE NOTED POOR ADHESION CAN ALSO BE ATTRIBUTED TO INSUFFICIENT OR POOR SITE PREPARATION (LIGHT CLEANING) WHICH MAY RESULT IN LESS THAN OPTIMAL INTERCONNECTIVITY WITH THE HOST SITE. ADDITIONALLY, KRYPTONITE IS CONTRAINDICATED FOR "USE IN A CURRENTLY INFECTED FIELD OR SURGICAL SITE LOCATED NEAR AN INFECTION" AND "USE IN PTS WITH THE FOLLOWING; A RECENT UNTREATED INFECTION." IT IS NOT CLEAR WHAT MAY HAVE CONTRIBUTED TO THE NOTED INFECTION. THERE ARE SEVERAL FACTORS WHICH MAY HAVE PLAYED A ROLE IN CREATING AN INFECTION, INCLUDING BUT NOT LIMITED TO; SURGICAL PROCEDURE, IMPROPERLY STERILIZED SURGICAL INSTRUMENTS, PERSONNEL OR DEVICE.

    Description of Event or Problem · 1

    THE PT COMPLAINED TO THE DOCTOR CONCERNING PAIN. THE DOCTOR REVISED THE SURGICAL AREA AND NOTICED THE KRYPTONITE MATERIAL WAS LOOSE AND NOT ADHERENT. THE DOCTOR NOTED THERE WAS A POSSIBLE INFECTION IN THE SURGICAL AREA. THE DOCTOR EXPLANTED THE MATERIAL.

    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-05 03092011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other