BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-03185

    MDR report key: 3150323 · Received June 6, 2013

    Report

    Report Number
    2520274-2013-03185
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 11, 2013
    Report Date
    May 10, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, 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. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH TROCHANTERIC FIXATION NAIL CONSTRUCT ON AN UNSPECIFIED DATE. REPORTEDLY THE PATIENT FELL AND CONSEQUENTLY THE PATIENT SUSTAINED A NEW FRACTURE NEAR THE KNEE. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2013, FOR REVISION SURGERY. THE SURGEON REMOVED ALL HARDWARE. THE PATIENT WAS REVISED WITH A LATERAL ENTRY LONG RECON NAIL TO COVER THE OLD INJURY AND REPAIR THE NEW FRACTURE. REPORTEDLY ALL HARDWARE WAS INTACT. THIS REPORT IS FOR AN UNKNOWN LOCKING SCREW. THIS IS 3 OF 3 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249643 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention