BEUDAMED
    FDA Adverse Event Other Summary report: N

    KRYPTONITE-X RADIOPAQUE LIQUID BONE COMPLEX

    MDR report key: 1652380 · Received April 5, 2010

    Report

    Report Number
    1226001-2010-00006
    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
    Removal / Correction Number
    1226001-03/29/10-001-R
    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 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 IN THIS SURGICAL PROCEDURE/ CONDITION WOULD NOT HAVE BEEN APPROPRIATE. KRYPTONITE-X RADIOPAQUE LIQUID BONE COMPLEX IS NOT INDICATED FOR USE WHERE 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 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 REVISION SURGERY WAS PERFORMED ON A FAILED CLAVICLE PLATE WHERE KRYPTONITE-X RADIOPAQUE LIQUID BONE COMPLEX WAS USED AS A FILLER TO STOP ROTATION. IN THE REVISION SURGERY, IT WAS REPORTED THAT THE KRYPTONITE-X RADIOPAQUE LIQUID BONE COMPLEX HAD NOT HARDENED TO THE SURGEONS 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 05072009

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN