BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTREMILOCK FOOT PLATING SYSTEM

    MDR report key: 6962218 · Received October 19, 2017

    Report

    Report Number
    2027754-2017-00008
    Event Type
    Injury
    Date Received
    October 19, 2017
    Report Date
    August 21, 2017
    Manufacturer
    OSTEOMED LLC
    Product Code
    HRS
    PMA / PMN Number
    K133437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2020 THE FDA REQUEST US TO REVIEW THE COMPLAINT (B)(4) AND TO RESUBMMIT THE INITIAL REPORT. AFTER THE REVIEW OF THE COMPLAINT AND FILE SUBMITTED IT WAS FOUND THAT THE INITIAL REPORT FOR THIS ADVERSE EVENT FAILED ON (B)(6) 2017. A FOLLOW-UP #1 WAS SUBMITTED AFTER THE COMPLETION OF THE INVESTIGATION ON (B)(6) 2017. THIS FORM IS THE RESUBMISSION OF THE INITIAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2017, OSTEOMED WAS NOTIFIED OF A CASE USING EXTREMILOCK FOOT IN WHICH THE PATIENT HAS METALLOSIS. OSTEOMED WAS AWAITING FURTHER DETAILS FROM THE DISTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743549 EXTREMILOCK FOOT PLATING SYSTEM EXTREMILOCK FOOT PLATING SYSTEM HRS OSTEOMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention