BEUDAMED
    FDA Adverse Event Other Summary report: N

    KRYPTONITE BONE CEMENT

    MDR report key: 2031280 · Received March 16, 2011

    Report

    Report Number
    1226001-2011-00002
    Event Type
    Other
    Date Received
    March 16, 2011
    Date of Event
    January 5, 2011
    Report Date
    February 4, 2011
    Manufacturer
    DOCTOR'S RESEARCH GROUP, INC.
    Product Code
    GXP
    PMA / PMN Number
    K091382
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEVERAL IDENTIFIED EVENTS SURROUNDING THIS CASE MAY HAVE BEEN SERIOUS CONTRIBUTING FACTORS. FIRST, KRYPTONITE IS CONTRAINDICATED FOR "USE IN A CURRENTLY INFECTED FIELD OR SURGICAL SITE LOCATED NEAR AN INFECTION". SECONDLY, KRYPTONITE IS CONTRAINDICATED FOR "USE FOR STRESS BEARING APPLICATIONS (E.G., MANDIBULAR SEGMENT REPLACEMENT)". LASTLY, THE CURRENT KRYPTONITE LABELED PRECAUTIONS IDENTIFIED THAT "THE EFFECTS OF PREPARING KRYPTONITE BONE CEMENT WITH ANY SUBSTANCE OTHER THAN THE PROVIDED COMPONENTS (INCLUDING ANTIBIOTICS AND BLOOD) IS NOT KNOWN. THE FORCE IMPOSED BY THE PATIENT TO BREAK THE WIRES MAY HAVE BEEN SUFFICIENT IN NATURE TO BREAK THE ADHESION BOND CREATED BETWEEN THE BOND AND/OR PLATE. NO DOCUMENTATION WITHIN THE DHR WAS FOUND THAT WOULD INDICATE A NONCONFORMANCE TO SPECIFICATION THAT COULD HAVE CONTRIBUTED TO THIS EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT A PROCEDURE TO REPAIR A BROKEN MANDIBLE UTILIZING A PLATE, WIRES AND KRYPTONITE WHERE KRYPTONITE BONE CEMENT WAS USED. THE MANDIBLE WAS BROKEN WHILE THE PATIENT WAS INTOXICATED. THE AREA WAS INFECTED AND THE SURGEON USED VANCOMYCIN POWDER MIXED WITHIN THE KRYPTONITE BONE CEMENT TO ASSIST WITH THE TREATMENT OF THE INFECTION. THE EXACT AMOUNT OF VANCOMYCIN WAS NOT KNOWN; HOWEVER, 2 GRAMS OF MATERIAL WAS IDENTIFIED. THE PATIENT UNDERWENT A SUBSEQUENT REVISION SURGERY TO REMOVE THE WIRES WHICH HAD BEEN BROKEN WHILE ATTEMPTING TO VOMIT WHILE INTOXICATED. DURING HIS REVISION THE AREA WAS AGAIN INFECTED AND THE MATERIAL WAS OBSERVED TO NOT HAVE ADHERED TO THE BONE OR PLATE. THE MATERIAL WAS NOTED AS BEING "HARD".

    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 06292010

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK