BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-04577

    MDR report key: 3241924 · Received July 22, 2013

    Report

    Report Number
    2520274-2013-04577
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR 1 UNKNOWN SCREW. IMPLANT DATE UNKNOWN. THE INVESTIGATION COULD NOT BE COMPLETED AND A MANUFACTURING EVALUATION CAN NOT BE PERFORMED. NO CONCLUSION COULD BE DRAWN AS THE DEVICE IS NOT BEING RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. THIS DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 1

    THIS REPORT IS FOR 1 UNKNOWN SCREW WHERE IT WAS REPORTED THAT AN 8 HOLE CONDYLAR PLATE BROKE DUE TO NONUNION. THE PLATE WAS REMOVED ALONG WITH 14 UNKNOWN SCREWS AND REPLACED WITH A RETROGRADE NAIL. PATIENT HAS HEALTH ISSUES WITH DIALYSIS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 4 OF 15 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340826 HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention