BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHRONOS WEDGE ½CIRC 7° 25*35*7

    MDR report key: 2882405 · Received December 20, 2012

    Report

    Report Number
    2520274-2012-04233
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    December 2, 2009
    Manufacturer
    SYNTHES
    Product Code
    MQV
    PMA / PMN Number
    NON-US
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED OCTOBER 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    THE EU COMPLAINT HANDLING UNIT REPORTED THAT THE CHRONOS APPEARS TO ACTUALLY STOP BONE GROWTH. SURGEON COMPLAINED THAT HE HAS PERFORMED 6 HTO PROCEDURES USING CHRONOS AND ALL 6 CASES HAVE GONE TO NON-UNION AND REQUIRED REVISION WITH EITHER AUTOLOGOUS BONE GRAFT OR JUST REMOVAL OF THE CHONOS. SURGEON STATES THAT SOME OF THE PATIENTS HAVE SOME IMPRESSIVE XRAYS WITH THE CHRONOS APPEARING TO ACTUALLY STOP BONE GROWTH ACROSS THE OSTEOTOMY. AT THE TIME OF REVISION THE CHRONOS IS A WHITE CHALKY SUBSTANCE WITH NO DISSOLUTION OR INCORPORATION. SURGEONS CURRENT FEELING IS THAT CHRONOS IS AN IMPEDIMENT TO BONE UNION, INTUITIVELY THIS MAKES SENSE AS THERE IS NO REASON WHY A NONBIOLOGIC CALCIUM RICH COMPOUND SHOULD INDUCE ANY BONE REGROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHRONOS WEDGE ½CIRC 7° 25*35*7 CHRONOS MQV SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention