BEUDAMED
    FDA Adverse Event Other Summary report: N

    KRYPTONITE BONE CEMENT

    MDR report key: 1631498 · Received March 12, 2010

    Report

    Report Number
    1226001-2010-00001
    Event Type
    Other
    Date Received
    March 12, 2010
    Date of Event
    September 24, 2009
    Report Date
    February 12, 2010
    Manufacturer
    DOCTOR'S RESEARCH GROUP, INC.
    Product Code
    GXP
    PMA / PMN Number
    K091382
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT CLEAR WHAT MAY HAVE CONTRIBUTED TO THIS EVENT. THERE ARE SEVERAL FACTORS THAT MAY HAVE PLAYED A ROLE IN CREATING AN INFECTION, INCLUDING BUT NOT LIMITED TO; SURGICAL PROCEDURE, IMPROPERLY STERILIZED SURGICAL INSTRUMENTATION, PERSONNEL, OR DEVICE. 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". NO DOCUMENTATION WITHIN THE DHR WAS FOUND THAT WOULD INDICATE A NONCONFORMANCE TO SPECIFICATIONS THAT COULD HAVE CONTRIBUTED TO THIS EVENT. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    A PT UNDERWENT A CARDIAC PROCEDURE WITH A STERNAL CLOSURE. APPROXIMATELY EIGHT (8) MONTHS POST-OP, A SECOND STERNAL CLOSURE WAS REQUIRED DUE TO A PSEUDOARTHROSIS (NON-UNION). KRYPTONITE MATERIAL WAS NOT UTILIZED IN THE ORIGINAL PROCEDURE. IT WAS REPORTED THROUGH THE DISTRIBUTOR THAT A SOFT TISSUE INFECTION DEVELOPED A FEW DAYS POST-OP AFTER THE REVISION STERNAL CLOSURE, WHICH WAS TREATED WITH VAC. NO REVISION SURGERY WAS REQUIRED. THERE WERE NO NOTED ISSUES WITH THE KRYPTONITE MATERIAL. THE IDENTIFIED PRODUCT AND PRODUCT CODE IS DESIGNATED FOR EXPORT ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KRYPTONITE BONE CEMENT BONE CEMENT GXP DOCTOR'S RESEARCH GROUP, INC. KRYP-Z-03 04232009

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK