BEUDAMED
    FDA Adverse Event Other Summary report: N

    KRYPTONITE BONE CEMENT

    MDR report key: 2594056 · Received May 23, 2012

    Report

    Report Number
    1226001-2012-00002
    Event Type
    Other
    Date Received
    May 23, 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
    GM
    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 OBSERVED NOTICEABLE DIFFERENCES (E.G., VISCOSITY, MIXING, EXPANSION, ETC.) WITH THE SUSPECT KITS. THE KRYPTONITE MATERIALS PERFORMANCE, AS DESCRIBED IN THIS EVENT, WAS CONSISTENT WITH PRODUCT EXPECTATION IN THAT EXPANSION IS DOCUMENTED WITH THE IFU AS WELL AS A KNOWN PRODUCT FEATURE. IT IS IMPORTANT TO NOTE THAT THE MAGNITUDE OF EXPANSION MAY INCREASE OR DECREASE DEPENDING ON A NUMBER OF FACTORS INCLUDING THE VOLUME OF MATERIAL APPLIED, AMBIENT HUMIDITY, THE AMOUNT OF BLOOD PRESENT, OR AMBIENT TEMPERATURES.

    Description of Event or Problem · 1

    A PATIENT WITH AN APPROXIMATELY 2 CM SUPRA-ORBITAL TUMOR ON THE LEFT SIDE, UNDERWENT A TUMOR RESECTION. AFTER RESECTION, 3CC'S OF KRYPTONITE MATERIAL WAS UNDER-FILLED AS A FILLER IN A PUTTY PHASE. APPROXIMATELY 6 MONTHS AFTER THE SURGERY, THE PATIENT COMPLAINED OF HIGH PRESSURE ON HIS LEFT ORBITAL CAVITY. AFTER COMPARING A NEW CT WITH THE IMMEDIATE POST-OP CT, IT WAS OBSERVED THAT THE KRYPTONITE MATERIAL INCREASED IN VOLUME AND IS NOW PLACING PRESSURE ON THE EYE.

    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 40 YR Other