BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KRYPTONITE BONE CEMENT

    MDR report key: 1633395 · Received March 12, 2010

    Report

    Report Number
    1226001-2010-00004
    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
    LOD
    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 THE SEROMA AND SUBSEQUENT INFECTION. SEROMAS HAVE BEEN ASSOCIATED AS A SURGICAL COMPLICATION. THERE ARE SEVERAL FACTORS THAT MAY HAVE PLAYED A ROLE IN CREATING AN INFECTION, INCLUDING BUT NOT LIMITED TO; THE SURGICAL PROCEDURE, REPEATED PROCEDURES WITHIN A SHORT PERIOD OF TIME, IMPROPERLY STERILIZED SURGICAL INSTRUMENTATION, PERSONNEL, OR THE DEVICE ITSELF. ADDITIONALLY, KRYPTONITE IS CONTRAINDICATED FOR "USE IN A CURRENTLY INFECTED FIELD OR SURGICAL SITE LOCATED NEAR AN INFECTION" AND "USE IN PATIENTS WITH THE FOLLOWING: C) A RECENT UNTREATED INFECTION". IT IS NOT CLEAR IF THE POTENTIAL INFECTION DEVELOPED AS A RESULT OF THE ORIGINAL SURGERY OR FROM THE SUBSEQUENT SURGICAL PROCEDURE. THE NOTED "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. THIS LOT OF PRODUCT WAS EVALUATED AS PART OF DRG QUARTERLY DOSE AUDIT REVIEW. THE FOLLOWING TESTS WERE PERFORMED AND MET THE ACCEPTANCE CRITERIA: BIOBURDEN (B)(4) IN ACCORDANCE WITH ANSI/AAMI/ISO (B)(4) (BIOBURDEN COUNT OF <1 CFU/SAMPLE) AND STERILITY (REPORT NO.:(B)(4)) IN ACCORDANCE WITH ANSI/AAMI/ISO (B)(4) (ZERO POSITIVE RESULTS). 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 REVISION STERNAL PROCEDURE WAS PERFORMED DUE TO THE DEVELOPMENT OF A SEROMA (POCKET OF BODY FLUID THAT SOMETIMES DEVELOPS IN THE BODY AFTER SURGERY) WHICH WAS TREATED WITH VAC. THE ORIGIN OF THE FLUID IS UNKNOWN. SEVERAL WEEKS LATER, THE PATIENT DEVELOPED AN INFECTION THAT REQUIRED A REVISION PROCEDURE. THE FIFTH REVISION FOR THIS PATIENT IN A ONE YEAR PERIOD. DURING THE REVISION PROCEDURE, A NUGGET OF KRYPTONITE WAS OBSERVED ON THE TOP OF THE STERNUM. THIS PATIENT WAS (B)(4) WITH A BMI 49. THIS PATIENT WAS AN EXTREME CASE, HAVING UNDERGONE 3 PRIOR PROCEDURES. THE FIRST PROCEDURE WAS AN AORTIC VALVE REPLACEMENT, APPROXIMATELY ONE YEAR EARLIER. A FEW WEEKS POST-OP, THE STAINLESS STEEL WIRES BROKE AND A SECOND PROCEDURE WAS REQUIRED TO REPAIR THE WIRES. SEVERAL MONTHS POST-OP FROM THE SECOND PROCEDURE, THE PATIENT DEVELOPED A DEHISCENCE AND ONCE MORE BROKE THE STAINLESS STEEL WIRES. A THIRD PROCEDURE WAS PERFORMED TO REMOVE THE STAINLESS STEEL WIRES AND REPLACED WITH AN UNIDENTIFIED TITANIUM PLATE. WHILE COMING OUT OF ANESTHESIA, THE PATIENT COUGHED PULLING THE SCREWS OUT OF THE BONE. KRYPTONITE WAS NOT UTILIZED IN ANY OF THE THREE PRIOR PROCEDURES. A FOURTH PROCEDURE WAS PERFORMED, TO REAFFIX THE OLD AND INSERT NEW TITANIUM PLATES. KRYPTONITE WAS UTILIZED IN THE FOURTH PROCEDURE. 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 LOD DOCTOR'S RESEARCH GROUP, INC KRYP-Z-03 09/22/2009

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR