BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IM NAIL

    MDR report key: 2833065 · Received November 5, 2012

    Report

    Report Number
    3034525-2012-00031
    Event Type
    Injury
    Date Received
    November 5, 2012
    Date of Event
    October 29, 2012
    Report Date
    November 5, 2012
    Manufacturer
    SIGN FRACTURE CARE INTL
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REVIEW OF THE SURGICAL DATABASE SHOWS AN X-RAY OF A BROKEN IM NAIL, HOWEVER, THE SURGEON MADE NO COMMENT ON THE CASE AND NO OTHER INFO IS AVAILABLE. REVIEW OF PT X-RAYS SHOWS THE NAIL BROKEN RIGHT AT THE F/X SITE WITH A LARGE NON-UNION PRESENT. REVIEW OF THE PTS POST-OP X-RAYS SHOWS THAT AN EXCHANGE NAIL PROCEDURE WAS PERFORMED TO REPLACE NAIL AND REPAIR THE F/X SITE. IT APPEARS THAT NAIL WAS SUBJECT TO DIRECT STRESS DUE TO A LARGE NON-UNION CAUSED FATIGUE FAILURE OF THE NAIL. NO INDICATION OF PRODUCT DEFECT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization