BEUDAMED
    FDA Adverse Event Other Summary report: N

    KRYPTONITE BONE CEMENT

    MDR report key: 2576927 · Received May 13, 2010

    Report

    Report Number
    1226001-2010-00013
    Event Type
    Other
    Date Received
    May 13, 2010
    Date of Event
    March 5, 2010
    Report Date
    May 12, 2010
    Manufacturer
    DOCTOR'S RESEARCH GROUP, INC.
    Product Code
    GXP
    PMA / PMN Number
    K091382
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEVERAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. IT MAY HAVE BEEN AN UNRELATED COMPLICATION OF SURGERY. THE FACTORS THAT MAY HAVE PLAYED A ROLE IN CREATING AN INFECTION; INCLUDE BUT ARE NOT LIMITED TO: SURGICAL PROCEDURE, IMPROPERLY STERILIZED SURGICAL INSTRUMENTS AND/OR WOUND SITE, PERSONNEL OR DEVICE. KRYPTONITE BONE CEMENT IS CONTRAINDICATED FOR "USE IN CURRENTLY INFECTED OR SURGICAL SITE LOCATED NEAR AN INFECTION" AND "USE IN PATIENTS WITH A RECENT UNTREATED INFECTION". INFECTIONS ARE ALSO NOTED AS POSSIBLE COMPLICATIONS WITHIN THE PRODUCT LABELING. THE OBSERVED MATERIAL CONSISTENCY, 'VERY HARD CLAY', IS LIKELY THE RESULT OF THE EXCESSIVE CEREBRAL FLUID NOTED BY THE SURGEON DURING THE INITIAL SURGERY. THE PRODUCT INSTRUCTIONS CLEARLY STATE SURGICAL WOUND AREA MUST BE DRY FOR BEST PERFORMANCE OF THE PRODUCT. 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 CRANIAL PROCEDURE INVOLVING AN EXTREMELY LARGE TUMOR AT THE BASE OF THE SKULL. THERE WAS A LARGE POCKET OF CEREBRAL FLUID WITHIN THE CAVITY. THE KRYPTONITE PRODUCT WAS USED TO RECONSTRUCT THE AREA WITH A LARGE BONE FLAP. THE BONE FLAP EDGES AND BURR HOLES WERE FILLED WITH KRYPTONITE BONE CEMENT. A REVISION WAS PERFORMED DUE TO THE DEVELOPMENT OF AN INFECTION. WHILE REVISING THE SITE, IT WAS NOTED THAT THE KRYPTONITE CEMENT WAS NOT AS HARD AS EXPECTED. THE SURGEON NOTED THAT THE MATERIAL WAS NOT PUTTY LIKE, BUT A "VERY HARD CLAY". THE BONE FLAP WAS SECURED WITH HARDWARE.

    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-10 11252009

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK