BEUDAMED
    FDA Adverse Event Other Summary report: N

    KRYPTONITE BONE CEMENT

    MDR report key: 2428930 · Received January 20, 2012

    Report

    Report Number
    1226001-2011-00005
    Event Type
    Other
    Date Received
    January 20, 2012
    Date of Event
    November 23, 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.

    Description of Event or Problem · 1

    THE DOCTOR USED KRYPTONITE MATERIAL DURING A MAXILLARY PROCEDURE. THE PT NOTIFIED THE DOCTOR THAT KRYPTONITE MATERIAL WAS PRESENT IN THE NASAL CAVITY. THE DOCTOR PERFORMED A REVISION TO REMOVE THE KRYPTONITE MATERIAL AND NOTED THAT THE MATERIAL WAS NOT ADHERENT.

    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 UNK Other