BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9MM TI CANNULATED TIBIAL NAILL-EX/360MM-STERILE

    MDR report key: 4173399 · Received October 15, 2014

    Report

    Report Number
    1719045-2014-10510
    Event Type
    Injury
    Date Received
    October 15, 2014
    Report Date
    September 18, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDS
    PMA / PMN Number
    PK040762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A REVIEW OF DEPUY SYNTHES MONUMENT DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A NON-UNION POST TIBIAL NAIL PROCEDURE. A REVISION WAS PERFORMED AND INCLUDED ANOTHER TIBIAL NAIL AND A FEMUR AUTOGRAFT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT NUMBER 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653780 9MM TI CANNULATED TIBIAL NAILL-EX/360MM-STERILE NAIL, FIXATION, BONE JDS SYNTHES MONUMENT 6818284

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention