BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7MM TI CANNULATED HUMERAL NAIL-EX/230MM

    MDR report key: 2893685 · Received January 2, 2013

    Report

    Report Number
    1719045-2013-00006
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    December 3, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDS
    PMA / PMN Number
    K033071
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: 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. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. IMPLANT DATE IS APPROXIMATELY (B)(6) 2011.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH HUMERAL NAIL AND SCREW CONSTRUCT ON AN UNKNOWN DATE, APPROXIMATELY (B)(6) 2011. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2012 FOR REMOVAL OF ALL HARDWARE DUE TO NON UNION. PATIENT WAS REVISED TO ORIF WITH LCP LARGE FRAG PLATE AND SCREW CONSTRUCT. THIS IS 1 OF 4 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301 7MM TI CANNULATED HUMERAL NAIL-EX/230MM HUMERAL NAIL JDS SYNTHES MONUMENT 6145345

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention END CAP, SCREWS