BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALLU-S PLATE SIZE 1 LEFT

    MDR report key: 1765509 · Received July 19, 2010

    Report

    Report Number
    9615741-2010-00031
    Event Type
    Other
    Date Received
    July 19, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 19, 2010
    Manufacturer
    NEWDEAL
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE PT HAD A FOOT INFECTION FOLLOWING INSERTION OF THE INTERNAL FIXATION PLATE. THE PT WAS ADMITTED TO THE HOSPITAL FOR THIS COMPLICATION. NO PATHOLOGICAL MICRO ORGANISMS WERE DETECTED ON CULTURE OF THE WOUND. THE SURGEON REPORTED THAT THE PT'S PROBLEM MAY BE CAUSED BY AN ALLERGY. HE REQUESTED A SAMPLE DEVICE OR ALLOY SAMPLE TO PATCH TEST THE PT FOR ALLERGY. INTEGRA HAS REQUESTED ADDITIONAL CLINICAL INFO FROM THE REPORTER. INTEGRA HALLLUFIX SCREWS WERE USED TO SECURE THE INTERNAL FIXATION PLATE: CATALOGUE NUMBER 117018, LOT EGDM X 1 AND LOT EHE X 1; CATALOGUE NUMBER 117020, LOT EG11; CATALOGUE NUMBER 117022, LOT EEZW X 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALLU-S PLATE SIZE 1 LEFT HALLU-FIX HRS NEWDEAL E9R8

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization