BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-02831

    MDR report key: 3133034 · Received May 29, 2013

    Report

    Report Number
    2520274-2013-02831
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE WAS IMPLANTED ON AN UNKNOWN DATE, APPROXIMATELY 9 MONTHS PRIOR TO EXPLANT. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT REVISION OF A DISTAL FEMUR PLATE THAT BROKE AT A SCREW HOLE ON AN UNKNOWN DATE. THE FRACTURE WAS NON-UNION AT THE TIME. THE ORIGINAL PLATE WAS IMPLANTED APPROXIMATELY NINE MONTHS EARLIER. A TIBIAL NAIL WAS ALSO REVISED WITH ANOTHER NAIL DUE TO A NON-UNION OF A SEGMENTAL TIBIA. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236156 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention