BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW CORTEX

    MDR report key: 2963747 · Received February 15, 2013

    Report

    Report Number
    2520274-2013-00853
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    October 21, 2010
    Report Date
    January 19, 2011
    Manufacturer
    SYNTHES
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RETURNED FOR REMOVAL OF TWO BROKEN SCREWS IN THE FALL OF 2010. IT IS BELIEVED THESE ARE TWO OF THE CORTEX TYPE SCREWS USED IN THE REPAIR OF THE RIGHT HUMERUS. THE MEDICAL RECORD INDICATES THERE WAS A NON-UNION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68569 SCREW CORTEX HWC SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention