BEUDAMED
    FDA Adverse Event Other Summary report: N

    KRYPTONITE BONE CEMENT

    MDR report key: 2519757 · Received March 30, 2012

    Report

    Report Number
    1226001-2012-00001
    Event Type
    Other
    Date Received
    March 30, 2012
    Date of Event
    November 30, 2011
    Report Date
    March 29, 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. THERE WERE NO NOTICABLE DIFFERENCES (E.G., VISCOSITY, MIXING, ADHESION TO MIXING BOWL, ETC.) WERE OBSERVED WITH THE SUSPECT KITS. POOR ADHESION CAN BE ATTRIBUTED TO INSUFFICIENT OR POOR SITE PREPARATION WHICH ALLOWS FOR A POTENTIAL SURFACE IMPEDIMENT BETWEEN THE HOST INTERFACE AND KRYPTONITE AND THUS ACTS AS A BARRIER TO ADHESION.

    Description of Event or Problem · 1

    THE SURGEON USED KRYPTONITE MATERIAL IN A MAXILLARY PROCEDURE. THE PATIENT NOTIFIED THE DOCTOR THAT THE MATERIAL WAS EXTRUDING THROUGH THE INCISION SITE. NO REVISION PROCEDURE WAS REQUIRED AS A RESULT OF THIS EVENT.

    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