BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-04849

    MDR report key: 3285084 · Received August 14, 2013

    Report

    Report Number
    2520274-2013-04849
    Event Type
    Injury
    Date Received
    August 14, 2013
    Report Date
    July 19, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR UNKNOWN TIBIAL NAIL EX X 1. IMPLANT DATE APPROXIMATELY 2 YEARS 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

    IT IS REPORTED THAT APPROXIMATELY 2 YEARS LATER OF POST TIBIAL NAIL IMPLANT, PATIENT RETURNED TO SURGEON COMPLAINING OF EXPERIENCING RECENT PAIN AND REQUESTING THE IMPLANT BE REMOVED. EXAM REVEALED THE FRACTURE WAS HEALED; SURGEON REMOVED ALL HARDWARE ON (B)(6) 2013. PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT FOR UNKNOWN TIBIAL NAIL EX X 1. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392963 JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other