BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTEX SCREW

    MDR report key: 2931133 · Received January 28, 2013

    Report

    Report Number
    2520274-2013-00664
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 9, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IMPLANT DATE REPORTED AS UNKNOWN DAY IN (B)(6) OF 2008. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT SUFFERED FROM A MIDSHAFT HUMERAL FRACTURE AND WAS IMPLANTED WITH PLATE AND SCREW CONSTRUCT, AT A DIFFERENT FACILITY, ON AN UNKNOWN DAY IN (B)(6) OF 2008. ON AN UNKNOWN DATE, POST-OPERATIVE X-RAYS SHOWED A NON-UNION. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2013, FOR REMOVAL OF HARDWARE. PATIENT WAS REVISED WITH TWO PLATES, AUTOGENEOUS ILIAC CREST BONE GRAFT, AND LAG SCREW COMPRESSION. THIS IS 2 OF 7 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36989 CORTEX SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention