BEUDAMED
    FDA Adverse Event Other Summary report: N

    KRYPTONITE BONE CEMENT

    MDR report key: 1973099 · Received January 21, 2011

    Report

    Report Number
    1226001-2011-00001
    Event Type
    Other
    Date Received
    January 21, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 14, 2010
    Manufacturer
    DOCTOR'S RESEARCH GROUP, INC.
    Product Code
    GXP
    PMA / PMN Number
    K091382
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT #: 12182009. ADDITIONAL MFR DATE: 12/18/2009. THE SPEED OF A CHEMICAL REACTION IS RELATED TO TEMPERATURE AND THE AUTOCATALYTIC AFFECT OF AN EXOTHERMIC REACTION. SIMILAR TO TEMPERATURE INFLUENCES; MATERIAL VOLUMES AND THE SHAPE OF THE MATERIAL WHILE CURING (SHEET VS. BALL) ALSO CONTRIBUTE TO THE INCREASE OF AN EXOTHERMIC REACTION. FURTHER TO THESE AUTOCATALYTIC AND VOLUMETRIC AFFECTS, ALSO NOTE THAT SURGICAL SITE (I.E., A WET ENVIRONMENT, ETC.) ALSO CONTRIBUTES TO SLOWING A REACTION. THE REACTION WOULD THEREFORE INCREASE FROM A 5CC KIT (SLOWER REACTION) TO A 10CC KIT (FASTER REACTION). THE OBSERVED MATERIAL CONSISTENCY, 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 INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    A PT UNDERWENT A CRANIAL FRACTURE, POSTERIOR ORBIT-INTRACRANIAL PROCEDURE WHERE KRYPTONITE BONE CEMENT WAS USED. A DURAL TEAR WAS OBSERVED WITH A SIGNIFICANT CSF LEAK. THE PERICARDIUM WAS PULLED OVER AND DURA SEAL SPRAYED ON SITE. DURA SEAL WAS NOT SPRAYED DIRECTLY ON THE KRYPTONITE. IT WAS NOTED, HOWEVER, THAT SOME MATERIAL MAY HAVE COME IN CONTACT WITH KRYPTONITE. UNUSED MATERIAL WAS PLACED ON THE SURGICAL TABLE FOR LATER USE IN FILLING THE BURR HOLES. THE KRYPTONITE MATERIAL WAS LEFT IN THE TRAY AND PLACED IN AN ICE BATH TO SLOW THE POLYMERIZATION PROCESS. WHEN THE SURGEON RETRIEVED THAT MATERIAL TO FILL THE BURR HOLES, THE MATERIAL HAD POLYMERIZED (HARDENED). THE SURGEON USED A SECOND KIT TO FILL THE BURR HOLES. A REVISION WAS PERFORMED THE NEXT DAY DUE TO INCREASED CRANIAL PRESSURE, LIKELY DUE TO THE CONTINUED CSF LEAK. WHILE REVISING THE SITE, IT WAS OBSERVED THAT THE KRYPTONITE BONE CEMENT WAS NOT AS HARD AS EXPECTED.

    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 11062010

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK