BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/440MM/LT-STERILE

    MDR report key: 2853346 · Received November 30, 2012

    Report

    Report Number
    1719045-2012-01216
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 4, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K040336
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT IMPLANTED WITH FEMORAL NAIL AND SCREWS ON (B)(6) 2012. IT WAS DISCOVERED THE PATIENT DID NOT HEAL. SURGEON RETURNED PATIENT TO O.R. ON (B)(6) 2012, THE HARDWARE WAS REMOVED, PATIENT WAS REVISED TO ANOTHER NAIL AND SCREWS. THIS IS 1 OF 4 REPORTS FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/440MM/LT-STERILE LATERAL ENTRY FEMORAL RECON NAIL-EX HWC SYNTHES MONUMENT 6489324

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention NAIL, SCREWS