BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREW

    MDR report key: 2841009 · Received November 20, 2012

    Report

    Report Number
    2520274-2012-03288
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    October 26, 2012
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO PART NUMBER OR LOT NUMBER PROVIDED, THEREFORE NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. NO FURTHER EVALUATION CAN BE PERFORMED WITHOUT THE RETURN OF THE DEVICE OR PART AND LOT NUMBER INFORMATION.(B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT IMPLANTED ON (B)(6) 2011. NAIL WAS DYNAMIZED ON (B)(6) 2011. IT IS REPORTED THAT PATIENT FRACTURE IS SLOW TO HEAL DUE TO HEAVY SMOKING. PATIENT PRESENTED TO SURGEON ON UNKNOWN DATE COMPLAINING OF PAIN. X-RAYS TAKEN ON UNKNOWN DATE REVEALED BROKEN NAIL. PATIENT WAS RETURNED TO OR ON (B)(6) 2012 FOR REMOVAL OF ALL HARDWARE. PATIENT WAS TEMPORARILY IMPLANTED WITH ANTIBIOTIC CEMENT NAIL. SURGEON WILL RE-EVALUATE PATIENT ON (B)(6) 2012 FOR POSSIBLE PLATE IMPLANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention NAIL, SCREWS