BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-04220

    MDR report key: 3222712 · Received July 12, 2013

    Report

    Report Number
    2520274-2013-04220
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 18, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IMPLANT DATE IS UNKNOWN. 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 UNDERWENT REVISION SURGERY FOR A FEMORAL NON-UNION ON (B)(6) 2013. A BROKEN 5.0 MM DYNAMIC LOCKING SCREW WAS REMOVED WITHOUT COMPLICATION. REPORTEDLY, THE SCREW HEAD POPPED OFF. IT WAS BROKEN IN TWO PIECES AND BOTH PIECES WERE RETRIEVED. IT IS UNKNOWN WHEN IT BROKE. A TOTAL OF NINE SCREWS AND ONE PLATE WERE REMOVED INTACT WITH THE EXCEPTION OF THE ONE BROKEN SCREW. THE INITIAL SURGERY DATE IS UNKNOWN. A NEW PLATE AND AN UNKNOWN NUMBER OF SCREWS WERE IMPLANTED. THIS REPORT IS FOR AN UNKNOWN DYNAMIC LOCKING SCREW. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321910 KTT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention