BEUDAMED
    FDA Adverse Event Other Summary report: N

    KRYPTONITE BONE CEMENT

    MDR report key: 1652379 · Received April 5, 2010

    Report

    Report Number
    1226001-2010-00007
    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 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 BONE CEMENT IN THIS SURGICAL PROCEDURE/ CONDITION WOULD NOT HAVE BEEN APPROPRIATE. KRYPTONITE BONE CEMENT 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 BONE CEMENT WAS USED AS A FILLER TO STOP ROTATION. IN THE REVISION SURGERY, IT WAS REPORTED THAT THE KRYPTONITE BONE CEMENT HAD NOT HARDENED TO THE SURGEON'S EXPECTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KRYPTONITE BONE CEMENT BONE CEMENT GXP DOCTOR'S RESEARCH GROUP, INC. KRYP-Z-03 03102009

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN