BEUDAMED
    FDA Adverse Event Other Summary report: N

    KRYPTONITE-X RADIOPAQUE LIQUID BONE COMPLEX

    MDR report key: 1652377 · Received April 5, 2010

    Report

    Report Number
    1226001-2010-00009
    Event Type
    Other
    Date Received
    April 5, 2010
    Date of Event
    November 4, 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

    DRG RECEIVED THE SYRINGE AND SAMPLE IN QUESTION AND DETERMINED THAT THE PRODUCT WAS IMPROPERLY MIXED. A SIZABLE AMOUNT OF KRYPTONITE-X COMPONENT "A" RESIN WAS NOT DISPENSED FROM THE SYRINGE RESULTING IN AN INCORRECTLY MIXED SAMPLE. 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

    IT WAS REPORTED THAT KRYPTONITE-X RADIOPAQUE LIQUID BONE COMPLEX WAS USED TO REPAIR A PREVIOUSLY (THE ORIGINAL PROCEDURE DID NOT USE KRYPTONITE PRODUCT) FIXED NON-UNION OF A SCAPHOID FRACTURE USING A COMPRESSION SCREW. KRYPTONITE-X RADIOPAQUE LIQUID BONE COMPLEX WAS ALSO USED IN THIS REPAIR TO "SPOT WELD" THE FRACTURE SITE. IT WAS REPORTED THAT THE MATERIAL HAD NOT HARDENED TO THE SURGEON'S EXPECTATION.

    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 06122009

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN