BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KRYPTONITE BONE CEMENT

    MDR report key: 1633398 · Received March 12, 2010

    Report

    Report Number
    1226001-2010-00002
    Event Type
    Malfunction
    Date Received
    March 12, 2010
    Date of Event
    November 2, 2009
    Report Date
    February 12, 2010
    Manufacturer
    DOCTOR'S RESEARCH GROUP, INC
    Product Code
    GXP
    PMA / PMN Number
    K091382
    Product Problem
    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 PATIENTS WHICH THE FOLLOWING: C) A RECENT UNTREATED INFECTION". THE NOTED CEMENT-HARD NUGGET MAYBE AN INDICATION OF EXCESSIVE MATERIAL, INSUFFICIENT OR IMPROPER SITE PREPARATION AND/OR IMPROPERLY PLACED MATERIAL IN THE SURGICAL SITE BY THE SURGEON. NO DOCUMENTATION WITHIN THE DHR WAS FOUND THAT WOULD INDICATE A NONCONFORMANCE TO SPECIFICATIONS THAT COULD HAVE CONTRIBUTED TO THIS EVENT. A RETAINER SAMPLE FROM THE BATCH IN QUESTION WAS MIXED AND NO ISSUES WERE OBSERVED WITH MIXING OR HARDNESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE DISTRIBUTOR THAT A SOFT TISSUE INFECTION DEVELOPED A FEW WEEKS POST-OP WHICH REQUIRED A REVISION STERNAL PROCEDURE. A LARGE CEMENT-HARD NUGGET OF KRYPTONITE MATERIAL WAS ALSO REMOVED. 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 08262009

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK