BEUDAMED
    FDA Adverse Event Other Summary report: N

    KRYPTONITE BONE CEMENT

    MDR report key: 1652381 · Received April 5, 2010

    Report

    Report Number
    1226001-2010-00005
    Event Type
    Other
    Date Received
    April 5, 2010
    Report Date
    March 22, 2010
    Manufacturer
    DOCTOR'S RESEARCH GROUP, INC.
    Product Code
    GXP
    PMA / PMN Number
    K091382
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE SEVERAL FACTORS THAT MAY HAVE PLAYED A ROLE IN NOT ALLOWING THE KRYPTONITE MATERIAL TO FULLY HARDEN, INCLUDING BUT NOT LIMITED TO; INSUFFICIENT OR IMPROPER SITE PREPARATION, TOO MUCH BLOOD WITHIN SURGICAL SITE, OR IMPROPER MIXING. IT WOULD ALSO APPEAR THAT THE USE OF KRYPTONITE MATERIAL IN THIS SURGICAL PROCEDURE/CONDITION WOULD NOT HAVE BEEN APPROPRIATE. KRYPTONITE BONE CEMENT IS NOT INDICATED FOR USE WERE INTRINSIC STABILITY TO THE BONY STRUCTURE IS REQUIRED. IT WAS ALSO STATED THAT CONTINUED BONE BLEEDING WAS OBSERVED. THE LOT NUMBER WAS NOT AVAILABLE AND THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS WERE NOT PERMISSIBLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE IDENTIFIED PRODUCT AND PRODUCT CODE IS DESIGNATED FOR EXPORT ONLY.

    Description of Event or Problem · 1

    A PLIF PROCEDURE WAS PERFORMED AT L4/L5 WHERE KRYPTONITE BONE CEMENT WAS USED. DUE TO A TUMOR, THE SURGEON REMOVED A PORTION OF THE L4 AND L5 VERTEBRAL BODIES AND THE L4/L5 DISC. THE KRYPTONITE BONE CEMENT WAS UTILIZED TO FILL THE VOID AND ACT AS A LOAD SHARING MEDIUM. A PEDICLE SCREW SYSTEM WAS USED TO FURTHER STABILIZE THE SEGMENT. THE AREA WAS DRIED AS MUCH AS POSSIBLE, SOME BONE BLEEDING HOWEVER CONTINUED. UPON SITE CLOSURE, THE KRYPTONITE BONE CEMENT HAD EXPANDED SOMEWHAT BUT WAS STILL WITHIN THE POSTERIOR BORDER OF THE VERTEBRAL BODIES. APPROXIMATELY 10 DAYS POST-OP, THE PATIENT PRESENTED WITH NUMBNESS THROUGH THE BUTTOCK REGION AND A REVISION SURGERY WAS PERFORMED. DURING THE REVISION SURGERY, IT WAS OBSERVED THAT THE KRYPTONITE BONE CEMENT HAD EXPANDED BEYOND EXPECTATION AND PUSHED INTO THE CANAL. DURING REMOVAL, IT WAS NOTED THAT THE KRYPTONITE MATERIAL WAS NOT HARD BUT CLAY LIKE IN CONSISTENCY. THE SURGEON REPORTED THAT THE KRYPTONITE MATERIAL HAD SET ENOUGH TO PROVIDE VERTICAL LOAD BEARING STABILITY BUT WASN'T 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. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN