BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL

    MDR report key: 2944118 · Received February 5, 2013

    Report

    Report Number
    2520274-2013-00777
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 10, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. (B)(6). 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

    A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: (B)(6): PATIENT WAS ENROLLED IN STUDY AND IMPLANTED WITH NAIL ON (B)(6) 2012. ON (B)(6) 2013 NAIL WAS REMOVED BECAUSE OF HYPERTROPHIC PSEUDOARTHROSIS. PATIENT WAS REAMED AND A LARGER NAIL WAS IMPLANTED. X-RAY AND CT SCAN WERE TAKEN ON AN UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49199 NAIL JDS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention