BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM TI CANN TIBIAL NAIL-EX W/PROX BEND 360MM-STERILE

    MDR report key: 3980795 · Received August 5, 2014

    Report

    Report Number
    1719045-2014-10352
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    July 7, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDS
    PMA / PMN Number
    PK040762
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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 HARDWARE REMOVAL WAS PERFORMED ON (B)(6), 2014, DUE TO A BROKEN TIBIAL NAIL. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6), 2013. THE HARDWARE WAS REMOVED AND THE PATIENT WAS REVISED TO ANOTHER NAIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT INJURY REPORTED. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458009 11MM TI CANN TIBIAL NAIL-EX W/PROX BEND 360MM-STERILE NAIL,FIXATION,BONE JDS SYNTHES MONUMENT 7362751

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention