BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2820331 · Received November 6, 2012

    Report

    Report Number
    2520274-2012-02893
    Event Type
    Injury
    Date Received
    November 6, 2012
    Report Date
    October 8, 2012
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO PART OR LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING A PROCEDURE TO EXPLANT A TIBIAL NAIL AND SCREWS. THE PATIENT WAS IMPLANTED WITH THE TIBIAL NAIL ON (B)(6) 2011. REPORTEDLY, THE PATIENT IS FULLY HEALED HOWEVER, COMPLAINED OF PAIN FROM THE SCREW HEADS. ALL HARDWARE WAS EXPLANTED ON (B)(6) 2012. THIS IS REPORT # 3 OF 8 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW SCREW HWC

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention