BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW CORTEX

    MDR report key: 2971256 · Received February 21, 2013

    Report

    Report Number
    2520274-2013-01070
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 23, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON AN UNKNOWN DATE WITH PLATE AND SCREWS. DURING A FOLLOW UP APPOINTMENT, DATE UNKNOWN, THE SURGEON NOTICED THE PATIENT'S ANKLE HAD A WEIRD ANGLE TO IT AS IF THE DISTAL TIBIA FELL VARUS. AN X-RAY, DATE UNKNOWN, REVEALED A NON UNION OF THE DISTAL TIBIA. IT WAS NOTED THAT THE SURGEON FOLLOWED STANDARD PROTOCOL AND ALLOWED WEIGHT BEARING AFTER 10 WEEKS AND NOTICED THE DEFORMITY ON FOLLOW UP. HARDWARE WAS REMOVED, DATE UNKNOWN, AND PATIENT WAS REVISED TO A MEDIAL DISTAL TIBIA PLATE WITH 8 OR 9 SCREWS. NO FURTHER INFORMATION IS AVAILABLE FROM THE HOSPITAL FACILITY. THIS IS 6 OF 11 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77083 SCREW CORTEX KWP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention