BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI DUAL CORE LCKNG SCREWT25 STARDRIVE 70MM F/IM NAILS

    MDR report key: 2971056 · Received February 21, 2013

    Report

    Report Number
    1719045-2013-00384
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 23, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDS
    PMA / PMN Number
    K040762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH TIBIAL NAIL ON (B)(6) 2012. IT WAS DISCOVERED ON AN UNKNOWN DATE THE PATIENT HAD A NONUNION. PATIENT RETURNED TO OR ON (B)(6) 2013 FOR REMOVAL OF IM NAIL, NAIL EXCHANGE, AND BONE GRAFT DUE TO NON-UNION. THIS IS 3 OF 8 REPORTS FOR THIS EVENT..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76895 5.0MM TI DUAL CORE LCKNG SCREWT25 STARDRIVE 70MM F/IM NAILS DUAL CORE LCKNG SCREWT25 JDS SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention