BEUDAMED
    FDA Adverse Event Other Summary report: N

    KRYPTONITE-X RADIOPAQUE LIQUID BONE COMPLEX

    MDR report key: 1652378 · Received April 5, 2010

    Report

    Report Number
    1226001-2010-00008
    Event Type
    Other
    Date Received
    April 5, 2010
    Date of Event
    August 21, 2009
    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-X RADIOPAQUE LIQUID BONE COMPLEX TO FULLY HARDEN, INCLUDING BUT NOT LIMITING TO; INSUFFICIENT OR IMPROPER SITE PREPARATION, TOO MUCH BLOOD WITHIN SURGICAL SITE, OR IMPROPER MIXING. IT WOULD ALSO APPEAR THAT THE USE OF KRYPTONITE-X RADIOPAQUE LIQUID BONE COMPLEX IN THIS SURGICAL PROCEDURE/CONDITION WOULD NOT HAVE BEEN APPROPRIATE. KRYPTONITE-X RADIOPAQUE LIQUID BONE CEMENT IS NOT INDICATED FOR USE WERE INTRINSIC STABILITY TO THE BONY STRUCTURE IS REQUIRED. NO DOCUMENTATION WITHIN THE DHR WAS FOUND THAT INDICATES A NONCONFORMANCE THAT COULD HAVE CONTRIBUTED TO THIS SPECIFIC EVENT. 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 FRACTURED CLAVICLE PROCEDURE WAS PERFORMED USING KRYPTONITE-X RADIOPAQUE LIQUID BONE COMPLEX TO CAPTURE THE FRAGMENTS AND CLAMP THEM IN PLACE UNTIL SET PRIOR TO PLATING, NEGATING THE NEED FOR MULTIPLE SMALL FRAGMENT SCREWS. THIS WAS ACHIEVED, BUT UPON REMOVING THE CLAMPS AT APPROXIMATELY 45 MINS. THE KRYPTONITE-X RADIOPAQUE LIQUID BONE COMPLEX WAS STILL SOFT AND NOT HOLDING TOGETHER AS HOPED. K WIRES WERE UTILIZED TO HOLD THE LARGER FRAGMENTS IN PLACE WHILST THE PLATE WAS POSITIONED AND SECURED. THE FINAL RESULTS WERE VERY GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KRYPTONITE-X RADIOPAQUE LIQUID BONE COMPLEX BONE CEMENT GXP DOCTOR'S RESEARCH GROUP, INC. KRYP-X-03 05072009

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN