BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IM NAIL

    MDR report key: 2802991 · Received October 16, 2012

    Report

    Report Number
    3034525-2012-00029
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 17, 2012
    Manufacturer
    SIGN FRACTURE CARE INTERNATIONAL
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REVIEWED SURGEON'S DATABASE REPORT WHICH GAVE LITTLE INFO ABOUT THE FRACTURE, HOWEVER WE RECEIVED AN E-MAIL FROM THE SURGEON INDICATING THAT THE FRACTURE WAS DUE TO A FALL. DR (B)(6) RESPONDED TO THE EMAIL AND NOTED THAT THE PT ALSO HAD A NON-UNION AT THE F/X SITE. I REVIEWED THE PT X-RAYS AND CONFIRMED THE NON-UNION AND BROKEN IM NAIL. PT FELL CAUSING A BREAK OF THE IM NAIL WHICH WAS AGGRAVATED BY A NON-UNION AT THE F/X SITE. NO INDICATION OF PROJECT DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IM NAIL IM NAIL HSB SIGN FRACTURE CARE INTERNATIONAL IM NAIL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization