BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL

    MDR report key: 2874085 · Received December 14, 2012

    Report

    Report Number
    2520274-2012-04006
    Event Type
    Injury
    Date Received
    December 14, 2012
    Report Date
    November 8, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, 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 NAIL AND SCREWS FOR A RIGHT MID SHAFT FRACTURE ON (B)(6) 2012. PATIENT RETURNED TO ANOTHER SURGEON FOR A FOLLOW UP VISIT, DATE UNKNOWN, AND IT WAS DISCOVERED THE FRACTURE SITE GAPPED AND WENT ON TO A NONUNION. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2012, HARDWARE WAS REMOVED AND THE PATIENT WAS REVISED TO AN ORIF WITH BONE GRAFT. THIS IS 1 OF 3 REPORTS FOR THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention NAIL, SCREW