BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIN

    MDR report key: 3983475 · Received August 5, 2014

    Report

    Report Number
    MW5037611
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    January 1, 2008
    Report Date
    August 5, 2014
    Manufacturer
    UNK
    Product Code
    HTY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2008, PT WAS IN A MVA WHICH REQUIRED SURGERY ON HIS BACK, HIP, SHOULDER, LEG, ARM AND PELVIS. DURING THE SURGERY, THE SURGEON IMPLANTED PINS, PLATES AND WIRES FOR MULTIPLE FRACTURES THE PATIENT SUSTAINED. FROM 2008-2011, PT HAD MULTIPLE HOSPITAL VISITS DUE TO THE IMPLANTS. PT C/O-CYSTS ON SPINE, PAIN ALLERGIC REACTION TO THE IMPLANTS AND (B)(6). IN 2011, PT HAD ALL IMPLANTS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456513 PIN PIN HTY UNK
    456514 PLATE PLATE HRS UNK
    456515 WIRE WIRE KTT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention